Associate Director QA

Associate Director Plant Quality Assurance
The Associate Director QA is a senior leadership role within Quality responsible for oversight of production operations & developing, implementing, and overseeing compliance programs and continuous improvement initiatives. The Associate Director will be responsible for leading and directing Quality staff, will be a Subject Matter Expert in their assigned area of responsibility and will be required to understand and grasp a broad range of quality related competencies. The Associate Director partners cross-functionally to embed a culture of quality, drive operational excellence, and support organizational growth.

Responsibilities

• Responsible for leading and directing Quality staff including managing their performance and supporting the development of their technical and decision-making skills.

• Provide QA oversight and support for production operations. This currently extends to formulation, Vial and Syringe Fill Finish aseptic operations and Inspection operations.  

• Collaborate with Operations & Engineering to resolve quality and compliance issues, including but not limited to Change Controls, Deviations and CAPAs.

• Support and represent Quality during audits and inspections.

• Support Lean Transformation and Operational Excellence initiatives.

The knowledge and skills necessary to perform the duties of the Associate Director PQA are typically acquired through the following combination of education, experience, and knowledge. 

Basic Qualifications

• University degree - Engineering or Science related discipline.

• Relevant experience (10 yrs.+) working in the pharmaceutical or biotechnology industry with a minimum 3+ years in a leadership role, or other combination of experience and educational background that may otherwise satisfy the requirements of the role

• Technical skills and demonstrated competencies across a broad range of quality related disciplines. 

• Experience working with dynamic cross-functional teams and proven abilities in decision making.

Preferred Qualifications

• Experience working in aseptic operations, protein formulation, vial and syringe filling.

• Knowledge of applicable Regulatory requirements.  Experience with Regulatory inspections.

• Excellent written and verbal communication skills.