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Summary of Objective:
The QA Manager – Document Control will lead the QA Document Control team across multiple production facilities in a regulated GMP environment. This position ensures the effective management and lifecycle maintenance of controlled documents, procedures, and records while fostering compliance with internal policies and external regulatory requirements. The role also includes driving strategic improvements to document control systems, mentoring staff, and promoting a collaborative work culture.
Essential Duties and Responsibilities:
- Provide direction and oversight to QA Document Control team across multiple facilities, ensuring operational excellence.
- Mentor and manage team members, fostering professional development and a collaborative, high-performing culture.
- Promote clear, concise, and timely communication to senior management and cross-functional teams.
- Oversee the issuance, revision, and archiving of GMP-controlled documents, including Batch Records, Testing Data Sheets, Equipment Log Books, and Quality System documents.
- Serve as the business process owner and administrator for the eQMS document module, ensuring continuous improvement and system optimization.
- Facilitate client approvals for Batch Records and manage periodic SOP reviews in collaboration with stakeholders.
- Conduct internal audits of the eQMS document module to ensure compliance with regulatory and organizational requirements.
- Support client audits and regulatory inspections by ensuring documentation readiness.
- Collaborate with cross-functional teams to address document control, aligning with broader business objectives.
- Identify and implement process improvements to enhance efficiency, compliance, and effectiveness within QA operations.
- Develop and maintain site-level metrics to monitor the performance of QA Document Control activities.
- Analyze data to identify trends, gaps, and opportunities for improvement, sharing actionable insights with leadership.
- Track and report compliance metrics, such as training completion rates, document approval timelines, and audit findings, to ensure consistent operational standards.
- Write and revise QA SOPs related to document control processes.
- Participate in investigations related to document control activities and recommend corrective actions.
- Perform other duties as assigned by senior management.
Special Demands:
- 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:
- 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:
- Bachelor's degree in a related field with 5-8 years of relevant experience in an FDA-regulated environment.
- 5+ years Document Control experience
- Previous experience with an electronic Quality Management System, MasterControl preferred
- Alternatively, a High School Diploma/Associate’s Degree with 10+ years of GMP experience.
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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.
