Description:
Senior Manager, Validation
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The Sr. Validation Manager is responsible for setting strategy and policies, and oversight of the Validation Department and programs and related activities including: Qualification and re-qualification of facilities, equipment, computer systems, utilities, equipment cleaning, cleanroom qualification, and process validation including aseptic processing. The scope includes all regulated areas of manufacturing: LAL, Media and Cell Therapy.
Primary Responsibilities
- Manage staff and workload of at least one validation supervisor and 3 - 6 validation specialists and numerous contract validation specialists. Provide direction, coaching and mentoring for routine and complex activities.
- Development and implementation of strategy and policies related to Validation. Development and oversight of the execution of Validation related documents throughout the system lifecycle, including development of a comprehensive Validation master plan covering equipment, utilities, sterilization, cleaning , aseptic processing, cleanroom qualification and computerized system validation
- Support change control, investigations, and PR’s, VMP’s and SOP updates. Determine levels of importance or risk to be assigned to elements under review to ensure validation efforts are directed at the systems which have the potential to impact product quality, efficacy, and data integrity using a variety of tools including GAMP 5 and Quality Risk Management
- Represent the validation group and defend policies, program, and validation documentation during audits, regulatory inspections Present a coherent and clear picture of validation effort to any reviewer or auditor, providing confidence in the installed system, process, facility or procedure. Provide validation expertise for issue resolutions to support deviations or CAPAs. and audit findings.
- Develop and approve cGMP documents including, but not limited to, Master Validation Plans, SOPs. Protocols and forms to improve validation efficiencies.
Safety
- Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
- Ensure that all team members comply with safety rules and regulations.
Quality Responsibility
- Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
Education
- Bachelor’s degree in life sciences or Engineering required.
Experience
- Minimum 10 years validation experience in a FDA regulated drug or biologics manufacturing facility. At least 5 years management experience or a Master’s degree or equivalent experience in life sciences or engineering with a minimum of six (6) years validation experience in the pharmaceutical or biotechnology industry, and at least 5 years management experience
- Experience in successful management of complex validation projects and authoring and/or reviewing validation documents.
Knowledge
- GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing and Part 11 compliance knowledge preferred. Comprehensive knowledge of Validation lifecycles for Computerized Systems and Process Control Systems and aseptic processing, sterilization validation, Cleaning validation and equipment and utility validation.
- Thorough understanding of industry standards and best practices computer system validation such as GAMP 5 and ASTM E2500, and data integrity requirements
Skills
- Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic. The ability to interface and communicate directly with clients may be required.
- Demonstrated Project Management abilities to lead and manage a high volume of simultaneous projects
- Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects. text.