Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

The Quality Control (QC) Microbiology Manager is responsible for the management and leadership of people, technology and budgets to support Manufacturing Operations.  Overseeing the QC Microbiology (QCM), Environmental Monitoring, QCM and Validation Compliance units, the position is responsible for the implementation of innovative improvement plans and Quality systems, providing expert advice to key customer departments and an enabler to meeting GXP standards.  

As a member of the Extended Leadership Team (ELT), you will play a critical role optimizing the supply of world-class, life-saving medicines to our patients by leading cross-functional collaborations to build a culture of understanding, belief and a commitment to excellence; enabling timely decisions that are consistent with the site’s goals and priorities; promoting wellbeing and developing a strong culture of inclusivity, equity and diversity; fostering simplification, removing roadblocks, and empowering continuous improvement and working as a cohesive team to build trust, excitement and knowledge.    

How You Will Achieve It

Technical 

• Challenge, influence and support practices, policies, systems, attitudes, and structures to enhance and ensure compliance, and alignment, with global regulatory requirements and Global Quality Standards. 

• Support the implementation of improvement plans to meet site strategic objectives. 

• Ensure appropriate service levels are met and maintain high level of quality and GXP in a highly regulated facility. 

• Responsible for the review of relevant deviations and CAPA related records, and quality documentation (including validation documentation and risk assessments). 

• Participates in the review of key performance targets and assists in the development of future performance targets to meet quality, customer and cost targets. 

• Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach their team. 

• Ensure active presence in the GMP work area and observe the work activity and practices within their role responsibilities. 

• Act as IMEx Element Owner and perform Structured Gemba. 

• Ensures all procedures within the QC and aseptic support business units meet the relevant compendial standards and are performed to these standards. 

• Supports quality audits to ensure processes are performed according to regulatory requirements (i.e. promotes and manages regular internal quality/product compliance audits). 

• Ensures all OOS and non-compliance investigations and reporting functions within the Business Unit are managed in a timely fashion and corrective/preventative measures implemented in