Head of Quality

Our Client, a growing and key player in the pharmaceutical industry, is seeking their next Head of Quality. We are in search of an outstanding leader with the ability to guide people effectively, tasked with devising and executing a comprehensive quality strategy for the site. The Head of Quality leader will oversee the QA and QC departments of the site which will consist of over 70 people total. This person will play a pivotal role in supporting their ambitious growth objectives while instigating a significant cultural shift within the quality division of their Organization.

Please note, this is an in-person position based at our Clients site in the Greater Birmingham, AL area.

Key Duties and Responsibilities:

Oversee the overall financial allocation and performance of the QC and QA divisions, while identifying and advocating for continuous enhancement opportunities within the function.

Participate actively as a member of the site's senior management team and the global Pharma Quality and Regulatory leadership team.

Efficiently strategize and coordinate both short- and long-term projects, encompassing process enhancements and capital planning.

Continuously advance Quality Management Systems to guarantee alignment with regulations, group standards, and the broader business strategy.

Deliver a technical support service as needed to other departments, including addressing customer inquiries and resolving complaints.

Interpret legislation and conduct exhaustive investigations into multiple immediate and underlying causes, subsequently formulating action plans to enhance the quality function.

Communicate effectively and exert influence across all levels of the Organization and with regulatory bodies responsible for quality.

Take ownership of and lead the site's Quality Management Review process.

Candidates Must Have:

MSc or PhD degree with previous experience in a Senior Quality position within the domains of cGMP API manufacturing, CDMO, or research organizations. A solid grasp of FDA regulations is imperative.

Profound familiarity with Quality Standards like ISO9001, EXCiPACT, and EU GMP, in addition to an in-depth understanding of quality prerequisites throughout the various stages of clinical development.

Demonstrated success in fostering a resilient and mature quality ethos within a global, matrix-driven organization.

Proven leadership abilities, capable of constructing inclusive and diverse teams, and a history of establishing and sustaining high-performance work cultures.

Proficiency in leading initiatives related to change management and cultural transformation.

An enthusiastic commitment to continuous improvement, coupled with an innate inquisitiveness and the capacity to challenge established norms in order to drive efficiency and innovation within the quality department.

Possession of a Quality Auditing qualification and prior auditing experience is a plus