Sr. Staff Program Manager engaging with PSG sites to ensure compliance with validation policies. Managing complex projects within the pharmaceutical sector to improve safety and efficiency.
Responsibilities
Engage with and support the sites within the PSG network
Ensure site adherence to global validation policies and procedures
Provide support for regulatory/customer audits, documents and engagements as needed to foster successful business outcomes
Support sites as needed with pre-inspection readiness within CQV space
Be viewed as a subject matter expert for commissioning and qualification programs, regulations, and requirements
Requirements
Bachelor's Degree in Engineering or related field
10+ years of related experience in the Pharmaceutical or related industry including experience in validation, engineering, operations, program and project management
Extensive knowledge of full validation lifecycle requirements for Steriles Manufacturing, Biologics, Clean Utilities and Support Services
Audit experience strongly preferred
Advanced knowledge of CQV for pharmaceutical equipment and systems (e.g Filling lines, Isolators, Autoclaves, Lyophilizers, Single Use Bioreactors and Mixers, WFI, Clean Steam, Process Gases, and ancillary equipment)
Proven track record leading medium to large-scale capital projects through commissioning and qualification
Advanced knowledge of applicable regulatory requirements (FDA, EMA, WHO, Annex 15, ISO, etc.) related to commissioning, qualification and validation
Strong analytical and problem-solving capabilities
Willingness to travel up to 20% as required, domestic/international
Working knowledge of deviation and quality record platform (i.e. TrackWise)
Benefits
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
Job title
Senior Staff Program Manager, Commissioning and Qualification
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