Manager, Quality Compliance
Experic
United Kingdom
Published yesterday
Compliance Management Systems / Technology
Experic is an industry-leading contract development and manufacturing organization (CDMO) and clinical trial supply services company. Our vision is to deliver innovative and scalable solutions for every phase of a product's life cycle from clinical to commercial. We offer advanced pharmaceutical manufacturing, packaging, and labeling technologies that can accommodate a variety of dosing and packaging formats. We take pride in our precision capabilities, state-of-the-art filling equipment, advanced technologies, and Class A regulatory compliant cGMP facilities. Our main goal is to provide our clients with personalized attention and ensure the smooth and successful completion of their pharmaceutical development programs.
We aspire to develop a team culture based on trust, integrity, ethical behavior, and compliance, with a relentless focus on delivering high quality results. If you value a collaborative work environment and are energized by the opportunity to truly make a difference, come and Experience the Experic difference. We believe in fostering a fair and respectful work environment that encourages open communication and continuous improvement. At Experic, you can experience a fulfilling career, do meaningful work, and grow professionally and personally. A successful candidate will bring their unique thinking, expertise, and approach while sharing our core values.
SUMMARY/OBJECTIVE: The Manager, Quality Compliance is responsible for execution and management of the quality assurance program, organization, and fostering the Quality culture at Experic. The incumbent will promote quality-driven products, processes and services to support the attainment of Experic's strategic financial and business performance initiatives per guidance by the Vice President, Quality. This individual shall have accountability and provide routine oversight of Experic's Quality Management System (QMS) including design, implementation and continuous improvement in the pharmaceutical manufacturing facility.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Serves as a Subject Matter Expert for Quality Compliance and cGxP Systems processes.
Review and maintain Experic's Quality Manual and Quality Policy and support wider aspects of the Quality
Management System to maintain compliance.
Leads and participates in continuous improvement projects for Quality Compliance. Utilize Continuous
Improvement tools as required.
Facilitates alignment of QMS and quality activities across company locations and departments to ensure
adherence to Experic's corporate quality policies.
Implement programs that establish and maintain a culture that fosters compliance with company rules and
all applicable federal, state, and local regulations.
Develops and improves processes for Document Change Controls, including impact evaluations, workflows
and cycle time for document closures. Ensures control of systems, processes and product through supporting
review and approval of change notices and engineering change controls/ change orders.
Assists in development and maintenance of Experic's Training Program and application including
management of training requirements, assessment of training impact, curricula design and assignment, etc.
Oversees internal audit program and conducts regular internal facility audits to ensure compliance to
Experic's quality management system and all applicable regulatory standards and requirements.
Designs and delivers training to Lead Internal Auditors.
Manage Quality Audits and Inspections (internal, customer and regulatory)
Drives Experic's CAPA program and ensures appropriate CAPAs are generated to increase compliance and
prevent repeat occurrences of deviations.
Manages the Customer and Regulatory auditing program by completing required pre-audit documentation,
hosting audits, developing appropriate corrective actions documented through the audit report responses
and ensuring proper implementation.
Maintain a systematic approach to sharing audit (customer and regulators) observations and associated
corrections with all site team members and also the corporate quality team.
Create, review and maintain appropriate Customer and Vendor Technical Quality Agreements and manage
the Quality Agreements process at Experic.
Lead Quality Management Reviews and Quality Review Board Meetings as required per procedures and
report applicable quality system metrics, KPIs and data to track against quality objectives.
Establish and maintain a robust program for complaints, product recalls and product retrievals.
Oversees the Nonconformance and CAPA processes.
Supports the electronic Quality Management System implementation and ongoing improvement projects.
Is available for other duties as required.
Is available for overtime as needed.
QUALIFICATIONS AND EXPERIENCE:
Bachelor's Degree in Science or Engineering with a minimum of 7 years of experience managing Quality
Compliance and Quality Assurance activities. Master's degree preferred.
Accredited Quality Certification (i.e. ASQ CQA, CQE or CBA) is preferred.
Experience with drug product (oral solid dosage forms preferred) development and manufacturing with
proficient knowledge of cGMPs and associated CMC regulatory considerations
Experience successfully leading event investigations, Root Cause Analysis and CAPA
Experience with electronic systems such as ERP, eQMS, MES, etc.
OTHER SKILLS, ABILITIES OR QUALIFICATIONS
The ability to operate in a fast pace, highly dynamic environment, at a detailed execution level, as well as on
a tactical/strategic level.
Demonstrated capability of interacting with senior leaders through the organization and maintaining credibility
and collaboration between the quality function and other business functions.
Proficiency in using Microsoft applications.
Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
Attention to detail and quality are critical to success.
Highly accountable for the results and outcomes of their responsibilities and understands the impact of their
efforts, results, and attitudes on others.
Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas of
team members, and assisting where help is needed yet is capable of highly independent work when efficiency
is required.
Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to
excel in and contribute to a rapidly growing company.
Forward thinking mindset with the ability to manage multiple projects and identify and resolve issues.
Demonstrated knowledge of industry regulations and best practice standards including but not limited to the
following:
o 21 CFR Part 210 & 211
o 21 CFR Part 11
o 21 CFR 1300
o EU Annex 11
o EudraLex Volume 4
o 21 CFR Part 820
o ISO 13485
o ISO 14971
o ISO 9001
Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to
work independently with limited supervision
Experience independently handling supplier audits as a lead auditor.
Experience participating in internal and external audits (e.g., FDA, Notified Body, Customer Inspections).
Demonstrate effective collaboration and teamwork.
Demonstrate experience working in a cGxP environment.
Effectively hires, develops, counsels, manages and motivates staff.
Writes and administers performance appraisals for department personnel.
Provide support within the Quality department and cross-functionally, as directed by Quality Executives.
Computer skills:
Computer software applications such as but not limited to MS Word, MS PowerPoint, MS Access, MS Excel, ERP Systems and electronic QMS.
Ability to effectively collaborate with others in a team environment.
Read, write, review and interpret documents such as standard operating procedures, manuals, batch
records, work instructions, specifications, protocols, quality agreements and contracts.
Legible Handwriting.
Communicate clearly in writing and orally.
Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios and
proportions to practical solutions.
Ability to work with mathematical concepts such as probability, statistical inference, Statistical Process
Control, Design of Experiments and Six Sigma problem solving methods.
Ability to apply concepts of basic algebra and geometry.
SUPERVISORY RESPONSIBILITIES: None
WORK ENVIRONMENT:
Standard office environment
PHYSICAL DEMANDS:
Office Environment (standing and sitting) requiring minimal physical exertion.
While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
The employee is occasionally required to sit and reach with hands and arms.
Ability to lift and/or move up to 50 pounds frequently preferred.
The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
TRAVEL:
Travel will be is required approximately 10% of the time, domestic and international.
The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.
We aspire to develop a team culture based on trust, integrity, ethical behavior, and compliance, with a relentless focus on delivering high quality results. If you value a collaborative work environment and are energized by the opportunity to truly make a difference, come and Experience the Experic difference. We believe in fostering a fair and respectful work environment that encourages open communication and continuous improvement. At Experic, you can experience a fulfilling career, do meaningful work, and grow professionally and personally. A successful candidate will bring their unique thinking, expertise, and approach while sharing our core values.
SUMMARY/OBJECTIVE: The Manager, Quality Compliance is responsible for execution and management of the quality assurance program, organization, and fostering the Quality culture at Experic. The incumbent will promote quality-driven products, processes and services to support the attainment of Experic's strategic financial and business performance initiatives per guidance by the Vice President, Quality. This individual shall have accountability and provide routine oversight of Experic's Quality Management System (QMS) including design, implementation and continuous improvement in the pharmaceutical manufacturing facility.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Serves as a Subject Matter Expert for Quality Compliance and cGxP Systems processes.
Review and maintain Experic's Quality Manual and Quality Policy and support wider aspects of the Quality
Management System to maintain compliance.
Leads and participates in continuous improvement projects for Quality Compliance. Utilize Continuous
Improvement tools as required.
Facilitates alignment of QMS and quality activities across company locations and departments to ensure
adherence to Experic's corporate quality policies.
Implement programs that establish and maintain a culture that fosters compliance with company rules and
all applicable federal, state, and local regulations.
Develops and improves processes for Document Change Controls, including impact evaluations, workflows
and cycle time for document closures. Ensures control of systems, processes and product through supporting
review and approval of change notices and engineering change controls/ change orders.
Assists in development and maintenance of Experic's Training Program and application including
management of training requirements, assessment of training impact, curricula design and assignment, etc.
Oversees internal audit program and conducts regular internal facility audits to ensure compliance to
Experic's quality management system and all applicable regulatory standards and requirements.
Designs and delivers training to Lead Internal Auditors.
Manage Quality Audits and Inspections (internal, customer and regulatory)
Drives Experic's CAPA program and ensures appropriate CAPAs are generated to increase compliance and
prevent repeat occurrences of deviations.
Manages the Customer and Regulatory auditing program by completing required pre-audit documentation,
hosting audits, developing appropriate corrective actions documented through the audit report responses
and ensuring proper implementation.
Maintain a systematic approach to sharing audit (customer and regulators) observations and associated
corrections with all site team members and also the corporate quality team.
Create, review and maintain appropriate Customer and Vendor Technical Quality Agreements and manage
the Quality Agreements process at Experic.
Lead Quality Management Reviews and Quality Review Board Meetings as required per procedures and
report applicable quality system metrics, KPIs and data to track against quality objectives.
Establish and maintain a robust program for complaints, product recalls and product retrievals.
Oversees the Nonconformance and CAPA processes.
Supports the electronic Quality Management System implementation and ongoing improvement projects.
Is available for other duties as required.
Is available for overtime as needed.
QUALIFICATIONS AND EXPERIENCE:
Bachelor's Degree in Science or Engineering with a minimum of 7 years of experience managing Quality
Compliance and Quality Assurance activities. Master's degree preferred.
Accredited Quality Certification (i.e. ASQ CQA, CQE or CBA) is preferred.
Experience with drug product (oral solid dosage forms preferred) development and manufacturing with
proficient knowledge of cGMPs and associated CMC regulatory considerations
Experience successfully leading event investigations, Root Cause Analysis and CAPA
Experience with electronic systems such as ERP, eQMS, MES, etc.
OTHER SKILLS, ABILITIES OR QUALIFICATIONS
The ability to operate in a fast pace, highly dynamic environment, at a detailed execution level, as well as on
a tactical/strategic level.
Demonstrated capability of interacting with senior leaders through the organization and maintaining credibility
and collaboration between the quality function and other business functions.
Proficiency in using Microsoft applications.
Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
Attention to detail and quality are critical to success.
Highly accountable for the results and outcomes of their responsibilities and understands the impact of their
efforts, results, and attitudes on others.
Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas of
team members, and assisting where help is needed yet is capable of highly independent work when efficiency
is required.
Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to
excel in and contribute to a rapidly growing company.
Forward thinking mindset with the ability to manage multiple projects and identify and resolve issues.
Demonstrated knowledge of industry regulations and best practice standards including but not limited to the
following:
o 21 CFR Part 210 & 211
o 21 CFR Part 11
o 21 CFR 1300
o EU Annex 11
o EudraLex Volume 4
o 21 CFR Part 820
o ISO 13485
o ISO 14971
o ISO 9001
Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to
work independently with limited supervision
Experience independently handling supplier audits as a lead auditor.
Experience participating in internal and external audits (e.g., FDA, Notified Body, Customer Inspections).
Demonstrate effective collaboration and teamwork.
Demonstrate experience working in a cGxP environment.
Effectively hires, develops, counsels, manages and motivates staff.
Writes and administers performance appraisals for department personnel.
Provide support within the Quality department and cross-functionally, as directed by Quality Executives.
Computer skills:
Computer software applications such as but not limited to MS Word, MS PowerPoint, MS Access, MS Excel, ERP Systems and electronic QMS.
Ability to effectively collaborate with others in a team environment.
Read, write, review and interpret documents such as standard operating procedures, manuals, batch
records, work instructions, specifications, protocols, quality agreements and contracts.
Legible Handwriting.
Communicate clearly in writing and orally.
Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios and
proportions to practical solutions.
Ability to work with mathematical concepts such as probability, statistical inference, Statistical Process
Control, Design of Experiments and Six Sigma problem solving methods.
Ability to apply concepts of basic algebra and geometry.
SUPERVISORY RESPONSIBILITIES: None
WORK ENVIRONMENT:
Standard office environment
PHYSICAL DEMANDS:
Office Environment (standing and sitting) requiring minimal physical exertion.
While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
The employee is occasionally required to sit and reach with hands and arms.
Ability to lift and/or move up to 50 pounds frequently preferred.
The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
TRAVEL:
Travel will be is required approximately 10% of the time, domestic and international.
The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.