Associate Director, Quality Assurance (Manufacturing)

Description:

This position will provide management oversight and leadership for core facility compliance functions. Responsible for independent Internal Manufacturing and Laboratory Investigations (both Planned and Unplanned), Customer Complaint Investigations, CAPA program, Customer Complaint Investigations, Focused Internal Audits to evaluate potential compliance risks and take appropriate mitigation efforts and also alert senior management on potential issues.

Essential Functions:

• Responsible for independent Internal Manufacturing and Laboratory Investigations (both Planned and Unplanned).
• Responsible for Customer Complaint Investigations
• Responsible for Focused Internal Audits across all departments.
• Perform risk assessment for compliance and recommend corrective measures and preventative measures to mitigate potential compliance risks.
• Inform Senior Management of any activities/issues/decisions that may impact the compliance of the sites that may lead to regulatory action.
• Responsible for the CAPA Program
• Assist in the review of SOPs and other relevant documents where necessary.
• Participate in other compliance related projects as assigned by management.

 

Education:

• Bachelors Degree (BA/BS) Scientific discipline (e.g. Chemistry, Biology, Pharmacy ) - Required

Experience:

• 3 years or more in 3-10+ years of experience in pharmaceutical industry
• 3 years or more in Supervisory experience
• 3 years or more in Auditing experience.

Skills:

• Strong written and oral communication skills; technical writing ability; excellent organizational skills and ability to set priorities according to business needs; supervisory skills and ability to negotiate with other departments; - Advanced

Specialized Knowledge:

• Knowledge and experience in cGMP and FDA regulations, particularly 21 CFR part2l0 and 211 are a must.
• Ability to use Word, Excel and PowerPoint.
• Knowledge in electronic database use as applicable;