Senior Manager of Technical Program Management at Capital One driving complex programs in cloud operations resilience. Collaborating with cross - functional teams to deliver technological solutions with an innovative approach.
TS
Hybrid Senior Staff Program Manager, Commissioning and Qualification
Posted last month
About the role
- 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
Job type
Experience level
Salary
Degree requirement
Location requirements
Program Manager driving strategic initiatives for Bosta's Expansion Department while optimizing logistics operations. Ensuring alignment with IPO roadmap and managing high - value programs.
Program Manager driving compliance technology solutions for Fidelity's Corporate Services Technology. Analyze business needs, collaborate with teams, and ensure solutions meet requirements.
Senior Program Manager overseeing ambulatory CDI initiatives for BILH, leading program implementation and performance outcomes. Collaborating with cross - functional teams across multiple regions.
Utility Engagement Program Manager coordinating utility activities for data center development across QTS’s North American footprint. Engaging with power utilities to evaluate and secure capacity for new sites and expansions.
Development Program Manager overseeing telecom quality for design and construction activities in data centers. Coordinating with various teams to ensure compliance and effective delivery of projects.
Program Manager overseeing the Amplify program development and launch for North America at HP. Serving as the main contact for the sales force and managing program documentation and communication.
Program Manager managing LTSS HEDIS and quality activities across Medicaid LTSS markets. Collaborating with stakeholders for compliance and quality reporting across various states.
Program Manager leading strategic initiatives and executive governance for Vanguard's HNW division. Managing project delivery and facilitating collaboration across functional and regional partners.
Senior Coach guiding executive leaders to strengthen management practices and cultivate a culture of continuous improvement at Vanguard. Providing high - impact coaching and aligning daily work with strategic priorities.