QA Supervisor

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The QA Training Supervisor is responsible for managing the QA Training team and ensuring comprehensive training programs for the Manchester (MHT) sites, with occasional support for other locations. This role includes developing and delivering training programs, overseeing new hire orientation, tracking training metrics, and mentoring QA Training personnel to support compliance with GMP and regulatory requirements. The QA Training Supervisor plays a critical role in ensuring personnel are properly trained to perform their job functions in alignment with quality and compliance standards.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• Ability to communicate effectively through speech, vision, hearing, and written word.
• Capable of managing multiple projects simultaneously in a complex environment.
• Must be able to sit or stand for prolonged periods and occasionally lift up to 20 pounds.
• Requires occasional travel (~10%).

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Enclosed Document Control Filing Rooms: Frequent work in secure and enclosed filing rooms to manage, organize, and archive controlled documents in compliance with GMP requirements.
• Office Setting: Standard office environment with desk work, computer use, and meetings.
• Production Facility Areas: Occasional presence in cleanroom or production facility areas to collaborate with staff and support QA-related activities.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education

• Bachelor's degree in a relevant field with 5+ years of experience in a cGMP training environment, OR
• High school diploma or associate's degree with 10+ years of experience in a regulated industry.

Experience

• 2-3 years of supervisory experience in a QA training or compliance role.
• 5+ years of experience in GMP training within a regulated industry (pharmaceutical, biotech, or medical device).
• Experience with electronic Learning Management Systems (LMS) and training compliance tracking.
• Strong knowledge of FDA (21 CFR Parts 210, 211 & 820) and EU regulatory requirements related to training and personnel qualification.

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.