NHS Human Services, Inc.

General Description:

The QA Manager, DP Commercial Small Molecule is responsible for overseeing end-to-end quality operations and programs related to the commercial manufacturing of drug products at Contract Manufacturing Organizations (CMOs). This position ensures compliance with cGMP regulations for small molecule commercial product supply, including manufacturing, testing, packaging, release and distribution. The role ensures adherence to US, EU, CN, and ICH regulations, as well as BeiGene's internal quality processes and procedures.

Essential Functions of the job:

• Provide Quality support for cGMP external manufacturing operations at CMOs. Drive, lead and troubleshoot quality investigations at CMOs to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions.

• Provide Quality guidance of cGMP external manufacturing operations (CMO). Advise on Quality Agreement content and support Quality Agreement implementation and updates.

• Ensure CMOs are compliant for regulatory inspections and monitor progress of inspections. Perform on site quality visit (PIP) as required. Participate in quality audits that directly impact assigned projects.

• Review and approve CMO documents, including batch records, change controls, deviations, specifications and validation protocols/reports.

• Provide quality support for batch disposition of drug product.

• Work with departmental key stakeholders and internal staff to ensure processes and procedures remain in a compliant state globally.

• Review relevant GMP documents for compliance to company SOPs, quality systems and regulatory requirements.

• Proven leadership in driving projects to completion, including quality investigations, complaints, CCs, CAPAs and audit inquiries

• Author/Review standard operating procedures related to function and department and identify opportunities to streamline systems and processes.

• Work with regulatory to author and review quality sections of regulatory submissions.

• Oversight and management of complaint investigations, including partnership with CMOs when necessary

• Other duties as assigned.

Supervisory Responsibilities:

• None

Experience

• Minimum 5+ years of experience in Quality function of pharmaceuticals or biotechnology industry.

• At least 2-3 years of experience specifically in small molecule drug product quality (preferably with commercial products).

Computer Skills:

• Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Education Required:

Bachelor’s degree or above in Science or related

Other Qualifications:

• Understanding of Quality best practices, including familiarity with Quality Systems Regulations and GxPs,

• Strong knowledge of Good Manufacturing Practices (e.g. EU, US, CN, PICS) and ICH guideline

• Experienced with CMO management.

• Experienced in supporting process improvement projects.

• Experienced in small molecule product quality, drug product quality experience is preferred.

• Ability to effectively manage time and progress tasks to meet timeline in a fast paced/dynamic environment.

• Familiarity with quality risk management principles and thoughtful risk taking approach to decision making.

• Experienced working cross-department with CMC, regulatory and SC. Ability to work independently with scientific/technical personnel.

• Effective oral and written communication skills.

• Oral and written proficiency in English required.

Travel:

Occasional domestic travel, as required.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.