The Manufacturing Quality Assurance (MQA) Supervisor oversees the MQA team, which provides on-the-floor Quality Assurance (QA) support for manufacturing activities. This role ensures the delivery of quality oversight and support for daily manufacturing activities, ensures compliance with current Good Manufacturing Practices (cGMP) and provides quality guidance across various manufacturing and QA processes.
Key Responsibilities:- Oversee 3 shifts and provide guidance, organization, and support to the MQA team.
- Create, maintain, and report on key performance metrics for the MQA Team.
- Review and update documents such as SOPs, etc.
- Train, mentor, and lead quality teams for routine MQA activities and through necessary changes and improvements.
- Collaborate with Manufacturing to ensure adherence to current Good Manufacturing Practices.
- Work closely with all levels of Manufacturing to resolve issues, implement solutions, and maintain ongoing communication with MFG management to uphold good manufacturing practices within the MFG Suites.
- Based on outcomes of QMRs, quality council, internal and external audit findings, Gemba Walks and MQA findings, identify, propose, and lead continuous improvement projects
- Lead meetings between MFG and QA
- Write and review deviations and CAPAs
- Execute MQA responsibilities as outlined in standard operating procedures (SOPs), which include:
- Daily compliance checks of manufacturing rooms in use
- Line clearance
- On-the-floor monitoring of manufacturing operations
- On-the-floor logbook and batch record review
Required Skills/Abilities:- At least 8 years' experience in a regulated/GMP industry required; experience in QA Pharmaceuticals or Biotechnology required.
- At least 2 years' people management experience required.
- Working knowledge of ICH, ISO, cGMP, USP, EU, and other relevant regulatory guidance/requirements. Specific knowledge of 21 CFR 210, 21 CFR 211, ICH Q7, ICH Q9, ICH Q10, Eudralex - Volume 4, is desired.
- Ability to work in a fast-paced environment consisting of internal and external team members with minimal oversight.
- Problem-solving skills with the ability to adapt to changing priorities and timelines.
- Strong leadership and communication skills, including establishment of clear expectations and development of metrics and KPIs to monitor performance and ongoing activities.
- Demonstrated ability to write effectively, present ideas publicly, and proactively share knowledge with others to encourage team development.
- Ability to build positive working partnerships with other department management teams to successfully support validation and commissioning timelines.
- Experienced with making decisions through critical reasoning to solve standard and involved problems that may impact multiple departments.
- Prior experience with clinical and commercial manufacturing is preferred.
- Requires the ability to gown into clean rooms and wear PPE.
- Occasional weekend, holiday, and second shift coverage required
The annualized salary range for this role is between $75,000.00 - $93,700.00.
