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

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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.

JOB DESCRIPTION:

Position Title: QA Supervisor – Training

Location: Manchester - MHT

Department: Quality Assurance

Reporting To: QA Manager/QA Director

Responsible For (Staff): No

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:

Training Program Oversight

• Manage and lead the QA Training team, ensuring effective training delivery for Manchester (MHT) sites and supporting other sites as needed.
• Develop, implement, and maintain comprehensive training programs to ensure compliance with GMP, FDA (21 CFR Parts 210, 211, & 820), and EU regulatory requirements.
• Oversee the New Hire Orientation program, ensuring new employees receive the necessary training for GMP compliance and company policies.
• Develop and maintain training curricula, materials, and SOPs related to QA training.
• Ensure that training programs are continuously updated to align with regulatory changes and best practices.
• Support and coordinate cross-training initiatives to enhance workforce flexibility and operational efficiency.

Training Metrics & Compliance

• Track and analyze training completion rates, effectiveness, and compliance metrics to ensure all employees remain current with required training.
• Generate and report training compliance metrics for management reviews, audits, and inspections.
• Ensure that training documentation and records are properly maintained in compliance with GMP and regulatory requirements.
• Support audits and regulatory inspections by providing training records and demonstrating training program effectiveness.

Team Development & Leadership

• Supervise, mentor, and develop QA Training personnel, providing coaching and career development opportunities.
• Establish clear performance expectations, conduct regular performance reviews, and provide ongoing feedback.
• Foster a collaborative and growth-oriented environment, ensuring the training team is well-equipped to support business needs.
• Lead continuous improvement initiatives to enhance training efficiency and effectiveness.

Additional Responsibilities

• Support site-wide training initiatives, including new system implementations, procedural updates, and quality initiatives.
• Partner with cross-functional teams to assess training needs and develop tailored solutions.
• Perform other duties as assigned.

QUALIFICATIONS:

Required:

• 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.
• 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.

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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.