Fantastic opportunity to be apart of the fastest growing Cell & Gene Therapy companies in the nation!

Essential Functions & Responsibilities:

Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department. Schedules, plans, staffing, and monitors daily operation of department based on projected client demands. Conducts routine walk throughs of the facility to ensure compliance with regulatory and quality practices. Approval of investigations and documentation of non-confirming events and OOS. Recommends process improvements to achieve greater efficiency within the department and between sites. Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness. Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns. Ensures staff are recruited and selected using merit principles. Ensures tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements and holding staff accountable for meeting expectations. Trains and develops staff, provides constructive performance feedback and appraisals, and takes appropriate corrective action to address performance and conduct issues.

Qualifications:

Bachelor's degree in Science or relevant field. Minimum of 7+ years of experience with analytical laboratory or within the biopharmaceutical industry or equivalent. Strong knowledge of FDA and EU regulatory standards. cGMP experience required. Strong knowledge of analytical test methods and philosophies. Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review. Understanding of quality system applications, including the training, deviations, CAPA management, etc. Experience in authoring, reviewing, and /or approving cGMP related documents (investigation, validation/qualification reports, SOPs etc.). About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.