Quality Assurance Manager - Burlington, United States - Kelly Science, Engineering, Technology & Telecom

Description

Kelly Science is seeking a Quality Assurance Manager for a client located near Burlington, MA.

This is a full-time, onsite position. Relocation assistance may be available for qualifying candidates.


Salary:
$125,000-165,000/year depending on 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 requirementsScientific 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.

Extensive experience with GCP/GLP compliance required.
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 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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