Senior Specialist, Quality Assurance - Biologics/Vaccine Development Quality (Hybrid)

Job Description

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.  

The Senior Specialist, Biologics/Vaccine Development Quality (BVDQ), Global Development Quality is responsible for quality oversight of process and analytical 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 and analytical 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 Assignments:

• 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 our 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 our 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 outsourced programs including travel to other countries (e.g., EU, etc.).  Travel may be 5% based 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.

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. Issue reports summarizing results and work with area to ensure resolution of audit findings. Notifies relevant management of unresolved issues/trends.

• Review and approve production and analytical documentation accompanying the release of Cell Banks, Seeds, and Drug Substance lots to ensure conformance to appropriate regulatory requirements. Audits information supporting retest or re-evaluation dating for clinical supply materials.

• Represent Development Quality on cross-functional and inter-departmental teams by providing quality guidance.

• Provide technical guidance to senior management in evaluating systems/tools. Assist Development Quality staff and client areas with the technical aspects related to the use of electronic audit tools.

Minimum Education required:  

• B.S. degree in an appropriate Science or Engineering discipline. Advanced education preferred.

Required Experience and Skills:  

• Minimum 5 years’ experience in the pharmaceutical/biotechnology industry with B.S. or 3 years