Quality Assurance (QA) Supervisor - Manufacturing

The QA Supervisor will coordinate with the Manager/Associate Director, Quality Assurance, the day-to-day activities of the Quality Assurance group in the support of the site’s Operations (manufacture, testing, shipment, etc.). This person will evaluate and implement systems, methods, techniques, and solutions to moderately complex quality and regulatory compliance issues, and be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership. Additionally, this role will assist with regulatory agency and client audits and monitor the implementation of any preventative and corrective actions. The QA Supervisor must have a thorough understanding in ICH guidance, FDA regulations, GMPs, and Quality Systems relevant to the manufacturing of pharmaceuticals. The role is expected to build strong collaborative relationships with internal and external stakeholders to drive compliance and continuous improvement of GMP operations.

Core Responsibilities:                                                                                                                   

• Define operational excellence locally to align with global objectives. Lead and influence teams of people internally and externally to meet QA Operations objectives. 
• Build and strengthen Veranova’s quality culture and compliance reputation through functional excellence and involvement in organizational forums.
• Provide talent development and mentorship. Manage and provide guidance to the QA team supporting GMP manufacturing activities, batch record review, and batch release.
• Educate staff on Quality practices, including new hire quality orientation and compliance training.
• Coach, mentor and develop QA staff.
• Provide quality expertise, and oversight of manufacturing processes across shift operations to ensure adherence to GMP standards.
• Evaluate complex quality or multi-disciplinary situations and make decisions utilizing risk-based approach. Oversight of CDMO performance to compliance and Quality Agreement expectations. 
• Responsible for Quality oversight to support the manufacturing and release of products, ensuring these activities are timely, efficient and productive while adhering to client’s requirements and operational and quality parameters.
• Ensure timely and effective communication with clients on Quality topics, addressing any concerns and providing updates on ongoing quality issues or regulatory matters.
• Participate in the review and approve controlled documents, including deviation, change control, CAPA reports, batch records, SOPs, and product and material specifications.
• Participate in the conducting and reviewing of product and/or lot-related deviations, complaints, CAPAs, change controls, and annual product quality reviews (APQRs).
• Prioritize work efforts to ensure adequate Quality resources are in place to meet all business functions, working proactively and reactively to meet business demands. 
• Other duties as assigned.

Qualifications: 

Required

• Minimum 9 years of quality assurance experience with an undergraduate degree in engineering, science or related field
• Minimum 7 years of quality assurance experience with a graduate degree in engineering, science or related field
• Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry
• Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements
• Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance
• Excellent analytical, written and verbal communication and presentation skills
• Experience driving complex projects with the ability to initiate, prioritize, and successfully complete tasks
• Proven experience working effectively in team situations and as an individual contributor
• Demonstrated behavior that models the Veranova culture to achieve an inclusive environment and exceptional business results
• Demonstrated networking and influencing skills; ability to collaborate and influence effectively across a broad range of associates spanning varied disciplines and responsibilities
• Previous people management and/or team leadership experience required
• A mindset that promotes a positive work culture.

Preferred

• Certified Lead Auditor certificate, or certification(s) in Lean manufacturing methods/tools such as structured problem solving, Lean Six Sigma, etc.