Associate Director, Quality Assurance - Third Party Quality Management - Hybrid

Job Description

The position will be heavily involved in close partnership with Active Pharmaceutical Ingredient (API) manufacturing contractors and technical personnel and interacting with their functional equivalents in Quality Disposition and Pharmaceutical Research and Development and, Procurement on strategic objectives utilizing external contractors including Good Manufacturing Practice (GMP) qualification as well as site/project selection.

Additionally, the incumbent would serve as the bridge between research and development, and Commercialization activities and develop strong working relationships with external quality management personnel. The incumbent would be the key quality representative attending and contributing to oversight and business review meetings with our company and contractor personnel to discuss projects, operational/quality, and overall performance topics.

In addition to the job-specific tasks discussed above, the incumbent is expected to execute on the following:

• Plans and facilitates high risk and highly complex Quality-related process reviews and/or investigations.

• Provides project direction in the area of expertise in own discipline (such as directing or facilitating teams involving source area representatives in a matrix management environment).

• Leads Quality-related reviews, cross-functional process teams, and/or investigations, serving as a subject matter expert.

• Engages in strategic planning activities across the Quality Unit and directly responsible for project planning and activities of self and indirect reports associated with team activities.

• Makes decisions and acts with authority to carry out actions as applicable.

• Coaches, mentors and develops colleagues in areas of expertise. Guides others in a matrix environment.

• Serves as a quality spokesperson on a variety of Quality or compliance-related issues.

• Identifies trends and/or potential compliance gaps and proactively guides the resolution of long-standing or significant issues affecting quality and efficiency.

• Interprets complex regulatory requirements for various audiences, reviews draft policies and standards.

Education Minimum Requirements:

• Bachelor's degree in engineering, Chemistry or related field.

Required Experience and Skills:

• Bachelor's Degree with 10+ years of relevant experience within the pharmaceutical industry or advanced Degree with 8+ years of experience.

Preferred Experience and Skills:

• Small molecule manufacturing is not required but preferred.

• Knowledge in Mandarin is not required but preferred

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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