Associate Director, Quality Control Microbiology

Job Description

We are seeking a Growth and Improvement minded Quality Control Microbiology Lead Associate Director that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We provide an inclusive and welcoming environment with supporting leadership behaviors because having a high performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world.

• Values and Standards | Our Steadfast Dedication to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Strategic Summary

Our ability to excel depends on the integrity, knowledge, imagination, skill, and diversity of people like you. To this end, we strive to create an environment of mutual respect and teamwork. As part of our global team, you will have the opportunity to partner with talented and dedicated colleagues while developing and expanding your career.

The Associate Director, Quality Control Microbiology / Sterility Lead at our Company's Facility will lead laboratory operations for the testing and disposition of Microbiology sampling of the GMP manufacturing and laboratory areas, KPI reporting and facilitating regulatory audits.  The individual in this role will provide guidance, cross-functional development, and technical expertise to the Microbiology team which is comprised of personnel in various stages of their career development.  

The Associate Director must be an advocate for maintaining a safe work environment and will be accountable for meeting and driving projects and change management ensuring commercial needs are met.  This includes the goals of schedule adherence and right-first-time execution of testing and will also include project management for effective startup within their areas of responsibility for new products to the facility. The Associate Director will be expected to lead the Microbiology team by providing guidance and strong partnership between Quality Operations, Laboratory Quality Assurance, and Manufacturing Operations.

The Associate Director will support key projects for Quality Operations aimed at elevating the compliance, process and method robustness, and performance of the areas within their responsibility.  As the direct lead for the area of responsibility assigned, the individual is expected to fully manage all aspects of assigned projects and run the business activities, including but not limited to: decision making, stakeholder management, issue identification and resolution, comprehension of capacity and demand, participation and driving the tier process, and uses this forum to escalate concerns and best practices.  Proactively partners with Laboratory Quality Assurance personnel to ensure compliance with regulations, guidelines, and procedures.  Ensures that all project work, process improvements and capital projects are timely, robust and in alignment with corporate goals. 

Key Functions

• Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Reports to the Quality Operations Laboratory Director, will manage approximately 15 direct reports and carry out supervisory responsibilities in accordance with our Company’s policies and guidelines.

• Microbiology / Sterility testing of GMP samples from multiple product areas, project management and sample matrix qualifications

• Contacting IPT areas when samples/tests discrepancies are observed for timely correction.

• Coordinates with other departments (such as Operations, Quality Assurance, Validation, and Technology) to gather all required information and documentation in relation to process improvement, implementation and/or investigations.

• Support audits and inspections to provide data and information on request.

• Comprehends and implements safety procedures and Good Manufacturing Practices