Senior Specialist, Quality Assurance - Hybrid

Job Description

The Senior Specialist, Biologics/Vaccine Development Quality (BVDQ), Global Development Quality is responsible for quality oversight of process development, and drug substance manufacturing within the Vaccine and Biologics modalities for pre-commercial products. In preparation for inspections, regulatory filings, and/or clinical supply campaign readiness, will independently perform or coordinate routine and specialized audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our company requirements. Independently review and approve production documentation accompanying the disposition of Cell Bank, Seeds, or Drug Substance lots to ensure conformance to appropriate regulatory requirements. In addition, the Senior Specialist independently proposes solutions to compliance issues or audit comments with client areas. The Senior Specialist may also operationally supervise Development Quality staff, contingent employees or loaned-labor.

Primary activities include:

• Maintain an expert level of knowledge related to specialized area of technical expertise or GMP requirements and industry trends as described in applicable worldwide regulations.

•  Advise supported areas on requirements for all assigned project responsibilities as related to quality and company standards and communicate project status to management.

• Independently audit and/or approve GMP documentation for applicable regulatory filings, clinical supply, development and technology transfer, facility and/or equipment qualification. Ensure compliance with regulatory and company requirements. Issue reports as necessary summarizing deficiencies. Work with areas to resolve any audit findings.

•  Act as Quality representative for in-house or outsourced manufacturing programs. Duties include compliance oversite of program-related activities, batch record review and approval, deviation and/or out-of-specification approval, etc.

• Support of Due Diligence/outsourced programs including travel to other countries (e.g., EU, etc.). Travel may be 5% depending upon program needs.

• Identify need for and/or develop SOPs to ensure practices are accurately reflected. Assist support areas in SOP and quality-related system development and approval.

•  Represent Development Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing quality guidance.

•  Independently prioritize activities in support of multiple projects.

•  Support preparations for regulatory agency inspections. May accompany regulatory agency officials, conducting inspections of facilities or operations in supported areas, including GMP Certification inspection.

•  Specific and/or additional duties may include, but are not restricted to:

• Independently conduct GMP facility, systems, or procedural audits/inspections of internal support areas and external contractors and suppliers engaged in manufacturing, testing, holding, or packaging of clinical supplies. Ensure compliance with applicable regulations, policies, and procedures. …