Associate Director, Quality Control

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Our Company in the United States and Canada is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our Company has codified its legacy for over a century. Ethical integrity, forward momentum, and an inspiring mission back our success to achieve new milestones in global healthcare.

Our Company's Manufacturing Division, is a team of energetic colleagues who are dedicated to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that is committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Accountable for developing, implementing, and overseeing the daily operations of a Quality Operations Laboratory group and ensuring that the laboratory is maintained in a state of GMP compliance, that all documentation is generated in accordance with GMP, and that all reported results are accurate.

Primary Responsibilities

• Provides direction to individual contributors (professional employees) and managers.

• Contributes to the performance and results of the department.

• Adapts departmental plans and priorities to address resource and operational challenges.

• Implements plans and priorities based on department, site, and divisional objectives.

• Accountable for oversight and compliance of method validation and transfers including approval of validation schedules, project plans, master plans, validation protocols and reports.

• Provides technical guidance to employees, colleagues, or clients.

• Anticipates and interprets client and/or customer needs to identify solutions.

• Demonstrate excellent people skills including the ability to effectively partner with staff from other departments.

• Demonstrate excellent written and verbal communication skills.

• Demonstrate strong presentation skills including the ability to prepare and deliver professional presentations to external business interests.

• Ability to work objectively and as a member of the site Quality Leadership team.

• Ability to invest time, as required, expediting, or completing assignments or projects. This shall include working non-standard hours such as evenings and weekends, as necessary.

• Demonstrate strong spreadsheet, word processing and database skills necessary to process and present technical data in a clear and concise manner.

• Demonstrate advanced computational skills including algebra, trigonometry, and basic statistics.

• Applies management skills to align staff activities with department objectives.

• Identifies and resolves technical and operational problems; partners with peers to resolve problems that cross into inter-related units.

• Makes decisions – guided by policies and procedures – that impact the unit’s ability to meet performance objectives.

• Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes.

• Forecasts resource needs; manages allocated budget.

• May design studies for assay validation

• Attend relevant seminars and ongoing training.

• Represent department during FDA and other Regulatory Agency Inspections

Minimum Education Required:

Bachelor’s degree in biology, Chemistry, Biochemistry, or other relevant Life Science discipline

Required experience and skills:

• Minim