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Head Of Process Validation
Biotechnology and BioPharma jobs, Worldwide
| Job ref: | J010857/VM |
|---|---|
| Position type | Permanent |
| Location | Worldwide |
| Industry | Biotechnology and BioPharma |
Vacancy details
An excellent opportunity has become available for a Head of Process Validation for a large company to be based in either America, UK, Germany or Italy. The Head of Process Validation will be responsible for providing guidance and support for all Process Validation activities across the network.
Job Description
- Participate and coordinate cross-functional teams responsible for the execution of major and minor Validation projects.
- Manage and lead various best practice projects, including implementing new standards across all sites to provide consistent and improved Process Validation executions.
- Develop Validation Standard Documents for both new and existing vaccine processes.
- Drive and share Validation Standards associated with Process Validation across sites (champion technical training rollout).
- Work with site staff to prepare budgets, schedules and business cases for Process Validation activities, and participate in presentations to both the Site and Operational Management Teams.
- Evaluate current site and project Validation organizational structures and develop plans to implement high performing Process Validation departments and staff. Ensure all functional areas are covered, eliminate any gaps, and remove non-value added work.
- Prepare monthly in-depth project status reports, documenting decisions, risk assessments, cost, schedule and results-oriented achievements.
- Contribute to IQP (Innovation, Quality & Productivity) productivity targets at sites.
- Coordinate and lead progress meetings with the site Process Validation Directors, Managers, Validation Engineers, and other associated stakeholders.
- Oversee site inspection responses and ensure they are followed up on, tracked, and system improvements are delivered across the network.
- Track the closure of all Process Validation gaps across each site.
Minimum Requirements
- B.S., M.S., or PhD in Chemical Engineering
- Expert knowledge of Process Validation with a diverse compliance background in cGMP manufacturing.
- Proven track record managing Process Validation and Technical Transfer activities for new and existing processes.
- Expertise in a broad range of vaccine and biotech processes.
- Ability to work/live overseas – Europe, Asia, LatAm, etc.
- A willingness and ability to travel, often for extended periods of time both nationally and internationally.
- Preferably trained in Six Sigma / Lean Manufacturing
- Project management skills, including creating / managing project budgets, resources (internal and external) and schedules.
- Demonstrated organizational and leadership skills.
- Demonstrated matrix management skills and clear ability to work effectively in cross functional team environments. Strong ability to lead global teams in a multicultural matrix environment.
- International Experience working in cross cultural and cross functional teams is desirable.
Apply for this job:
Quanta's recruiter for this job is Vicky Miller
- +44 (0) 1442 869 217
- E-mail Vicky
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