The Compliance Quality Assurance (CQA) Manager is responsible for leading and managing activities within the CQA team. This includes managing site Quality events, ensuring site Compliance, Document Control, Annual Product Quality Reviews (APQR), Quality Technical Agreements, site self-inspections, and Bulk Product dispositions.
Requirements
- Supervise, develop, manage, and train direct reports in Quality Systems and Lot Release
- Effectively hire, coach, and motivate staff
- Write and administer performance appraisals for department personnel
- Develop, support, and sustain appropriate metrics including processing and preparing trend data for presentation to management during monthly and quarterly reviews
- Manage the APQR process and deliver approved reports on time per the approved schedule
- Manage the Document Management System; create, review, and approve documents including SOPs, WIs and protocols
- Collaborate with the Global audit function to develop the annual supplier audit schedule and manage completion of audits against the schedule
- Establish annually the internal audit schedule and manage completion of the internal audits against the schedule
- Ensure the site maintains a constant state of inspection readiness
- Issue batch records to operations in support of the schedule
- Ensure timely disposition of semi-finished Drug Product
- Ability to conduct root cause analysis and risk assessments
- Review and approve non-conformances, CAPAs, and change controls related to the area of responsibility
- Ensure that the site and quality systems remain in compliance with changes to regulatory requirements
- Provide regulatory expertise to the technology transfer process, as needed
- Assure job objectives are met on a timely basis and escalate quality issues to the Site Head of Quality
- Proactively drive a culture of continuous improvement
- Communicate effectively/efficiently with others in a professional manner
- Manage a wide variety of tasks under critical time constraints
Benefits
- 3 weeks’ vacation plus floating holidays and sick leave
- 401(k) and Profit Sharing Plan
- U.S. Employee Stock Purchase Plan
- Comprehensive Medical, Dental, Vision, Life and Disability coverage
- Health and Dependent Care Flex Spending options
- Adoption assistance
- Tuition reimbursement
- Leverage Concierge/personal assistance services
- Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
- Gym, fitness facility and cell phone discounts
