QC Microbiology Group Leader

Business Introduction

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations;

it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.

We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

You will lead a team of Quality control scientists responsible for sampling, testing, method validation, and facility monitoring (as applicable) in a GMP environment. Demonstrate broad and thorough knowledge of scientific principles and QC processes and pharmaceutical products. Strong communication skills to generate various types of technical documents such as investigation reports and SOPs and Leadership skills to guide and/or collaborate with others to achieve their goals and expectations.

Ensure that the QC testing and method validation of all products/value streams is performed to GMP and company standards (Analytical Chemistry/Microbiological & facility testing as applicable).

• Direct, document and approve laboratory investigations for out of specification or atypical results.
• Provide clear leadership in setting connections between specific, measurable targets in the area with site strategy.
• Adopt participative management style that empowers the team by involving them in setting objectives, performance management, problem solving, decision making and continuous improvement.
• Provide clear leadership in the development of staff performance plans including a capability plan and departmental goals.
• Lead the team to deliver daily improvements (relating to safety, quality, customer service and cost).
• Demonstrate broad knowledge (e.g., various dosage forms) of the pharmaceutical industry, the drug development process and current regulatory requirements and environment. Evaluate manufacturing, packaging and cleaning validation protocols for scientific merit.
• Participate on interdepartmental projects teams within the site by providing leadership and decision making.
• Ensure safe laboratory practices and current GMPs are followed. Maintain high standards of tidiness and cleanliness in all areas and actively reduce waste of laboratory resources.
• Create and revise departmental SOPs, technical reports, product specifications and analytical test methods. Ensure these comply with above site documents (e.g. QMS, CAPs/ATS, Industry guidelines, etc.).
• Serve key roles in the programs involving but not limited to stability protocols, customer complaint investigations, annual review, retain samples, and instrument calibration and main point of contact for internal and external audits (e.g. FDA, MHRA, and GMP-A).

• Bachelor’s Degree + 4 years relevant pharmaceutical experience or associate's degree + 6 years relevant pharmaceutical experience or High School + 10 years relevant pharmaceutical experience.
• 5+ years’ experience in a regulated laboratory with hands‑on microbiology testing.
• Experience of providing QC testing support to at least one value stream.
• Developing knowledge and application of the Quality Management System (QMS).
• Experience leading work in teams to improve processes or resolve problems using OE/GPS tools.
• Experience in portfolio of products.
• Demonstrated ability to participate in product projects – command of ICH guidance (ICHQ), GMP requirements and FDA/EMEA regulations. Approve lab study protocols and ensure they are designed to be acceptable to regulators.
• Knowledge of company products and quality impact as it relates to those products.

• Master’s degree…