Sr. Manager/ Associate Director - Quality Assurance

Burlington, MA

Direct Hire

Compensation: $150k-185k base + 10-15% annual bonus

Candidate Role:

We are seeking an experienced QA professional to support and evolve the quality management systems and processes at our US Site located in Burlington, MA. This individual will have the opportunity to work in a fast-paced, high growth CRO environment serving leading pharma in biologic development and cell & gene therapy. This is a unique opportunity to join a dynamic team and play a key role in supporting next-stage growth of the Quality function.

This individual will report to the Sr. Director of Global GCP/GLP compliance and while working closely with the US Site VP and the Global Quality team. They will play a key role in expanding and shaping US-based Quality culture, including GCP and GLP compliant business units.

This is a full-time, onsite position. Title and salary commensurate with experience.

Responsibilities:

• Drive expansion of the Quality Management System(s) in the US.

• Lead and participate in third party and regulatory audits including preparation and responses.

• Oversee qualification of equipment, systems, and suppliers.

• Organize and supervise employee training.

• Create, revise, and review documents such as SOPs and work instructions.

• Oversee and develop CAPA, deviation, risk analysis and change control management.

• Communicate with domestic and international pharmaceutical and life science customers and auditors.

• Interacting, reporting, and collaborating with PGN Global QA team.

• Conduct QA in the company’s programs, including ensuring Data Integrity in processes, data packages and reports to the Company’s external pharma and gene therapy partners.

• Ensure appropriate definition, development, and implementation of Quality systems.

• Conduct inspections and internal audits in accordance with GCP, GLP and GCLP guidelines to ensure corrective actions are addressed in a timely fashion.

• Report on Key Quality Indicators (KQI) to track systemic issues and gaps to drive on-going continuous improvement.

Job requirements

• Scientific or Engineering Degree (BSc, MSc).

• Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP or GCP preferred).

• Ability to drive cultural changes and establish a strong quality mindset within the organization.

• Experience in preparation and participating in inspections by the FDA is highly preferred, and/or other accrediting audits as may be required for GLP or GCP compliant laboratories.

• Experience leading the accreditation/certification procedures for CAP/CLIA is desirable.

• Strong quality awareness and ability to apply quality knowledge in practical work.

• Ability to manage and coordinate personnel, as well as organize and drive performance of the quality assurance system.

• Experience in a people management role is strongly preferred.

• Prior experience collaborating with outside clients and regulatory bodies preferred.

• Excellent verbal and written communication, organizational, and critical thinking skills.

• Strong interpersonal skills and the ability to work independently and collaborate in a team setting.

• Attention to detail, execution of tasks, and accountability a must.

• Must be flexible, willing to take initiative, and highly collaborative.

• Integrity, commitment, and a motivated work ethic.

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Send resumes to Jacqueline.Sayoc@KellyScientific.com

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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.