QC Microbiology Group Leader

Role Summary

Location: Zebulon, NC, USA. 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).

Responsibilities

• 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 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 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).

Qualifications

• Required: 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.
• Required: 5+ years’ experience in a regulated laboratory with hands-on microbiology testing.
• Required: Experience of providing QC testing support to at least one value stream.
• Required: Developing knowledge and application of the Quality Management System (QMS).
• Required: Experience leading work in teams to improve processes or resolve problems using OE/GPS tools.
• Required: Experience in portfolio of products.
• Required: 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.
• Required: Knowledge of company products and quality impact as it relates to those products.
• Preferred: Master’s degree in microbiology, biology or a related field.
• Preferred: Ability to discuss and defend product data generated and specifications.
• Preferred: Operational knowledge of analytical chemistry/microbiology (as applicable), complex laboratory equipment, including ability to diagnose problems and identify appropriate actions.
• Preferred: Full understanding of the requirements and application of GMP principles in a laboratory environment.
• Preferred: Effective verbal and written communication on an individual and group basis targeted to appropriately audiences of several levels within the organization.
• Preferred: Approve validation of analytical equipment and activities related to test method validation.
• Preferred: Strong leadership skills with an ability to form strong win/win partnerships. Willingness to collaborate with external department colleagues to share best practices and exchange ideas. Support other teams when required.
• Preferred: Technical expertise in a broad range of analytical methodologies (HPLC, sample preparation, spectroscopy, etc.) or microbiological methodologies, with training practices to ensure staff are trained to a high standard.

Education

• Bachelor’s Degree in a scientific field with 4 years of relevant pharmaceutical experience, or Associate's Degree with 6 years, or High School with 10 years of relevant pharmaceutical experience.

Additional Requirements

• On-site requirement: 100% on-site.