Associate Director, Quality Assurance - CDMO

The Associate Director of Quality Assurance is responsible for leading the Veranova Quality Assurance team, managing quality oversight of the manufacturing process and operations. This includes leading and managing multiple QA teams for batch record review, batch disposition, and on the floor QA support to ensure GMP compliance across all stages of manufacturing, as well as disposition and release of starting materials and customer facing Quality program leads for each client. The person filling this role will be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards. 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: 

• Lead QA program and create a positive working culture by empowering others. 
• Define operational excellence locally to align with global objectives. Lead and influence teams of people internally and externally to meet site 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.
• 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.
• Support the development / amendment of Quality Assurance Agreements with clients, GMP vendors and key raw material suppliers.
• Review and approve controlled documents, including deviation, change control, CAPA reports, batch records, SOPs, and product and material specifications.
• Conduct and review product and/or lot-related deviations, complaints, CAPAs, change controls, and annual product quality reviews (APQRs).
• Developing, trending, and reporting relevant Quality Metrics associated with the area of responsibility.
• Build improved efficiencies by partnering with functional Leaders and Quality having a consistent presence on the floor.
• Ensure adequate Quality resources are in place to meet all business functions, working proactively and reactively to meet business demands. 
• Maintaining the QA Operations function in a state of compliance and Inspection readiness and participate in the support or leading of client audits and regulatory inspections.
• Other duties as assigned. 
   

Qualifications: 

Required

• Minimum 11 years of quality assurance experience with an undergraduate degree in engineering, science or related field or minimum 9 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
• Previous people management and/or team leadership experience 
• 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
• Experience with project management and gap assessment projects 
• Experience creating metrics for driving continuous improvement
• 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
• Excellent communication and interpersonal skills with the ability to lead, manage and develop cross-functional relationships.
• Analytical mindset with a strong attention to detail and problem-solving skills
• Demonstrated networking and influencing skills; ability to collaborate and influence effectively across a broad range of associates spanning varied disciplines and responsibilities
• 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.