Consulting Head of Quality Job at Tunnell Consulting
Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.
A client of Tunnell Consulting needs a Consulting Head of Quality. This is an exciting opportunity for a consultant to work on a cutting-edge (non-Covid) vaccine with a novel mechanism of action.
This role is remote, part-time and will average 16-20 hours per week (some weeks more, some weeks less depending on workflow). The role is slated to start in June 2023 and will run through the end of the year, with a possibility for extension.
The Consulting Head of Quality will own the entire Quality function from strategy to hands on execution. The consultant needs to be a deadline driven, a self- starter and highly self-directed. The consultant will need to be flexible and open to travelling occasionally to vendor sites for assessments.
The client is a virtual, pre-clinical stage biotech. Some of the client’s employees and all of the contractors work part-time. All laboratory work is conducted via partnerships, including with contract organizations. The time zones span 8 hours. Work is planned and managed via a cadence of meetings and utilization of documentation and collaboration tools.
Skills and Experience
- 7-10 years Quality experience in biologics, preferably in viral vaccines, ideally with live virus vaccines
- Pre-clinical - Early Stage biotech experience, pre-IND / pre-Phase 1 required
- Late stage clinical development and/or commercial experience
- Expert in GMP, GLP and GCP preferred (GxP)
- Experience in eukaryotic cell-based processes, mammalian cell culture and aseptic processing
- Well-versed in Document Management Systems, fit for stage of development
- Experienced in authoring fit-for-purpose Quality documents, including SOPs
- Experienced in working in virtual settings, with multiple third parties involved and aligned, to manufacture clinical trial material
- Quality Management Systems reporting expertise
- Experienced in assessments of third-party vendors
- Experienced in providing technical and quality review of MSAs and quality technical agreements
- FDA/CBER experience
- Experience working in a fully virtual environment
Education
Minimum Bachelor’s Degree in a biological science or equivalent discipline.
Tunnell is proud to be an Equal Opportunity / Affirmative Action / Female / Minority / Disabled / Veteran Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, child-birth, or related medical conditions), national origin, ancestry, age, disability, family care status, veteran status, marital status, military status, sexual orientation, gender identity, or any other characteristic protected by law. Tunnell makes reasonable accommodation for persons with disabilities to apply for employment.
Please be advised that Tunnell employees are required to be fully vaccinated against COVID-19 as per CDC guidelines and subject to legal requirements. In accordance with Tunnell’s COVID-19 Vaccination Policy, employees need to confirm that they are fully vaccinated or engage in an interactive dialogue with Human Resources to determine eligibility for a religious or medical exception, and whether making such an exception would pose an undue burden or undue risk of harm. Additionally, client-facing employees are also expected to comply with all current and future client requirements for COVID-19 safety, including but not limited to surveillance testing, masking requirements, social distancing, and any other requirements.
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