Job Description

Location : This role is based in the Lexington, MA area with a hybrid schedule of four days on-site and one day remote.

We are looking for an experienced Senior Director of Quality Assurance to join a dynamic team. Reporting directly to the VP and Head of Quality, this role will be instrumental in developing, overseeing, and maintaining compliance standards across key third-party partnerships and within the organization’s internal Quality systems. This position holds primary responsibility for ensuring adherence to GMP protocols supporting product manufacturing and distribution, while also overseeing batch disposition processes for both clinical and commercial products.

Key Responsibilities:

• Oversee the GMP Quality Assurance team to maintain quality and compliance standards.
• Develop and implement Quality objectives, managing risk and ensuring cross-functional compliance.
• Ensure quality control for manufacturing and distribution across clinical and commercial products.
• Manage compliance of third-party logistics providers and supply chain partners.
• Collaborate with external partners to support manufacturing and resolve quality issues.
• Prepare for and manage regulatory inspections and audits.

Required Qualifications:

• A minimum of 15 years in the pharmaceutical or biotech industry with a background in manufacturing, quality, and development for drug substances and products.
• 5+ years in a Quality leadership role with demonstrated success in managing external partners and ensuring compliant batch certification.
• Bachelor’s degree in a scientific discipline; an advanced degree is strongly preferred.
• Proficient understanding of global GMP/GDP standards, including EU Directives, ICH guidelines, and Swiss MPLO 812.12.1.

For more information, do get in touch with Patrcia.Sousa@lifescirecruitment.com

At Life Sciences Recruitment Ltd (LSR), we are a Global Life Science recruitment firm that specialises in partnering with start-ups and fast-growing biotech and pharmaceutical organisations.

Founded in 2021, we recognised the need for a company with a search firm's insights, knowledge and credibility but offering a contingent service.

As one of the most competitive and fast-paced industries globally, succeeding and growing in the life sciences business requires a combination of creativity, technical expertise, and business savvy. At LSR, to find the best talent for your organisation, our dynamic recruitment consultants tap into our unparalleled network of contacts and apply a quality-based approach to a contingent search model tailored to your needs. We provide the most sought-after candidates to fit your requirements, from temporary placement to Fortune 500 companies!

LSR is a privately owned and independent recruitment company focused on the Life Sciences industry. We are a subsidiary of Morgan Prestwich (MP), Europe's leading boutique Life Sciences executive search and advisory firm.

Contact us today to learn more about our recruitment services!

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