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Manager, QA OTF - Severn Maryland
Company: Disability Solutions
Location: Severn, Maryland
Posted On: 11/20/2024
Manager, QA OTFPosition SummaryCatalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--Catalent's Harmans/BWI, MD facility is a FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The campus features two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.The Manager, QA OTF Support is responsible for providing quality oversight for the "QA on the Floor" program in accordance with--Catalent policies, standards, procedures and Global cGMP.-- Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations--on the floor to resolve manufacturing issues.--This position is required to be present on the floor for 70% of the day.This position will follow a night schedule with start time between 7PM-9PM Monday-Friday with 8-hour shifts and is 100% on site at our Harmans/BWI, MD facility.--Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.The Role: - Provide oversight of the "QA on the Floor" program; manage the day to day operations in assigned area of the QA OFT department.
- Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines; build effective teams that apply their diverse skills and perspectives to achieve common goals; drive engagement and create a culture where employees are motivated to do their best.
- Oversee daily activity for the group to ensure quality results Performance management for direct reports; drives the "Quality on the Floor" program by facilitating the desired 'way of working' and a quality culture; plans and coordinates the activities of the OTF team to ensure coverage for all manufacturing activities
- Provide QA oversight, technical expertise and leadership across all aspects of product manufacturing and operations support; develop and update relevant procedures.
- Monitor, participate and oversee the real time batch record review process, including escalation of issues while on the floor; manage the resolution of QA OFT investigations and CAPAs; ensure quality events are captured, investigated and closed appropriately in the Trackwise system.
- Ensure that own and teams KPI's, plans, targets and objectives are effectively monitored and achieved. Including standard lead-times and supporting the Business goals for e.g. RFT and OTD/ OTIF
- Ensure manufacturing compliance with applicable procedures and batch records; review manufacturing shop floor documentation, including logbooks, calibrations etc
- Embrace and actively drive Practical Process Improvements (PPI). Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
- Partner with manufacturing and key stakeholders to prioritize projects aligning with the quality goals and objectives.
- Actively participates in training activities, managing their individual training plan; proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding is a success.
- Other duties as assigned.The Candidate:
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