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Product Variation Management (PVM) Lead

Santa Monica, CA 90404

Posted: 03/22/2024 Employment Type: Contract Job Category: Project Management Job Number: 599193 Is job remote?: No Country: United States

Job Description


Target PR Range: 63-73/hr
*Depending on experience

Product Variation Management (PVM) Lead will manage the business and system processes for managing product variations. As the client expands to more products, global jurisdictions and manufacturing sites, changes increase in complexity and the number of product lifecycle changes that require variation management and jurisdictional control (JC) is proliferating. The PVM Lead will manage the global cross functional PVM team and JC business processes, and ensure, from an end-to-end planning and execution perspective, that the right product version is supplied to the right jurisdiction at the right time, in line with the regulatory filing strategy and global implementation plan. The product variation planning process is complex and oversees changes end-to-end, from regulatory filing to global and regional planning, and to manufacturing site implementation. Responsibilities (include but are not limited to):
  • Lead a cross-functional matrix global PVM planning team that spans across all Technical Operations functions, IT, and Clinical Logistics
  • Own and manage the business process for managing product variations
  • Manage change management and communication of the new business process
  • Lead team meetings, manage the global PVM tracking tools, and monitor PVM and JC metrics
  • Responsible for overseeing product variations from strategy definition through implementation across all impacted jurisdictions and manufacturing sites
  • Collaborate with cross functional stakeholders globally, considering interdependencies across Tech Ops, manufacturing network, and other stakeholders as needed
  • Facilitate cross-functional SME assessment of product variation changes to determine the plan for implementation
  • Liaise between the global PVM planning team and the governance bodies responsible for product variation and lifecycle management strategy definition, for alignment between strategy and implementation rollout plan
  • Deep dive into functional areas and manufacturing site processes to understand complexities, interdependencies, risks, and facilitate alignment across functions
  • Monitor status of change control(s) enabling a variations implementation globally from initiation to approval to implement; change control ownership possible based on type of change

Requirements:
  • BS degree required, concentration in science / engineering / business management is a plus
  • Master's Degree and 3-5 years of operations or supply chain experience in life sciences industry or Bachelor's Degree and 5-7 years of operations or supply chain experience in life sciences industry
  • Experience in working with ERP business systems (preferably Oracle EBS)
  • Diverse experience in operations disciplines
  • Exceptional ability to communicate and collaborate across different stakeholders
  • Ability to operate at different levels, both strategically and tactically
  • Proven success in leading cross functional teams and ability to influence all levels of staff in a matrix organization
  • Experience in Project Management and / or with PM tools such as SmartSheet is a plus
  • Drive to seek clarity and think critically
  • Excellent verbal, and written communication skills, including presentations
  • Ability to manage ambiguity and simplify complexity
  • Ability to navigate competing interests to achieve a common solution that is aligned across different parties
  • Ability to learn quickly, and absorb and simplify information from multiple sources; connect the dots into a cohesive plan
  • Self-directed and able to work independently with minimal direction
  • Works well in a dynamic, fast-changing environment
  • Enthusiastic team player
*CO/NYC candidates might not be considered

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Santa Monica, CA

Discover your next career opportunity in the vibrant city of Santa Monica, California! This beachside gem, located in Los Angeles County, offers a perfect blend of work and play. With renowned art galleries like the Bergamot Station Arts Center, iconic landmarks such as the Santa Monica Pier, and a diverse culinary scene that caters to all tastes, Santa Monica provides a unique and exciting backdrop for professional growth. From strolls along the picturesque Palisades Park to catching a show at the historic Santa Monica Playhouse, this area beckons job seekers with its irresistible charm and endless possibilities. Explore our job listings and take the next step towards an enriching career in this dynamic region.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.