Are you interested in working with cutting-edge laboratory technology to improve quality and accelerate regulatory compliance? If so, this Quality Control Group Leader role could be an exciting opportunity to explore.

As Quality Control Group Leader, you will have responsibility to lead 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).

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• 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).

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree and 4+ years relevant pharmaceutical experience or * Associates degree and 6+ years relevant pharmaceutical experience or * High School Diploma and 10+ years relevant pharmaceutical experience.
• 5 years in a GMP (Good Clinical/Manufacturing Practices) regulated laboratory environment.
• Experience in a quality support role within the pharmaceutical industry.
• 2+ years of experience supervising a team.

If you have the following characteristics, it would be a plus:

• Master's degree in chemistry, biochemistry or related science field
• Ability to work in a highly regulated and complex environment.
• Ability prioritize/manage activities of Analytical Laboratory Infrastructure Support team.
• Experience of providing QC testing support to at least one value stream.
• Developing knowledge and application of the Quality Management System (QMS).
• Knowledge of company products and quality impact as it relates to those 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.
• Expert in portfolio of products. Discuss and defend product data generated and specifications.
• Experience of leading work in teams to improve processes or resolve problems using OE/GPS tools.

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