Sr. Specialist, External Quality Small Molecules Position Available In Mercer, New Jersey

Sr. Specialist, External Quality Small Molecules (Remote) Manager or Sr Specialist, External Quality Small Molecules In this position you will provide end to end quality support for external manufacturers and strategic partners, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards.

Key Responsibilities:

Provide quality support to ensure effective execution of quality systems at external manufacturing sites. Support quality oversight in the qualification and ongoing monitoring of external partners. Support the identification and resolution of quality issues and complaints, including review and approval of non-conformances and development of robust CAPA plans. Provide support to the escalation and issue management processes. Review and approve quality systems documentation, including batch documentation and annual product reviews. Assess change controls and execute activities for implementing changes. Review and approve validation documentation, technical studies, master batch records and specifications. Establish and maintain quality agreements. Monitor quality performance through key performance indicators; analyze data to identify risks and drive implementation of mitigation plans. Build relationships with internal and external partners to meet patient supply requirements. Support external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture. Support risk management initiatives necessary to improve performance. Write and implement quality procedures and work instructions. Collaborate to support health authority inspections and audits; monitor and follow-up on associated responses and commitments. Provide quality oversight for integration of external manufacturing facilities. Support a variety of projects both internally and with external manufacturers.

Qualifications:

Education:

A minimum of a Bachelor’s or equivalent University degree is required. A focus in life science, engineering, or physical science preferred.

Experience and Skills:

Required:

A minimum of 8 years working in a cGMP regulated environment for Manager Level A minimum of 5 years working in a cGMP regulated environment for Sr Specialist Level Experience supporting quality oversight for pharmaceutical (or equivalent) production, including manufacturing operations, cGMP compliance, and non-conformance investigation. Ability to work independently in support of a portfolio of products and external manufactures. Experience working on cross-functional project teams. Strong communication and influencing skills; demonstrates an ability to communicate at all levels of the organization.

Preferred:

Experience working with external partners. Experience with product transfer, new product introduction, and combination products. 9879839