Systems Manager IV

South San Francisco, CA 94080

Posted: 03/07/2019 Employment Type: Contract Job Number: 15229

Bayside Solutions is seeking a System Manager IV to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.

Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.

Our Company Bio:  Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.

You can find additional information on our company website at www.baysidesolutions.com.

System Manager IV:

Job Benefits:
  • An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
  • Work for a company that is local to the bay area and recognized as a leader of innovation.
  • Competitive compensation commensurate with experience.
  • This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.

Summary of Responsibilities:
  • Serve as IMP Quality Systems SME to collaboratively set direction, implementation and enhancement of GMP phase adapted PQS and global quality business processes with sufficient flexibility for operational and development needs. 
  • Understand and ensure that applicable regulatory requirements are incorporated into our global PQS.
  • Enable and balance out our global PQS to meet evolving business and regulatory needs, ensure sufficient flexibility for TR&D and enable the delivery of pipeline.
  • Lead and collaborate on development of global documents consistent with the overall global PQS document master plan; address and resolve identified issues for the TR&D stakeholders during the global review of the requirements.
  • Oversight and support of the implementation of the global PQS documents at the TR&D stakeholders.
  • Shape and coach phase appropriate/risk-based compliance and GMPs.
  • Lead, facilitate and/or manage global IMP Quality non-molecule PPM projects.
  • Represent TR&D stakeholders in global non-product related (Quality) projects.
  • Be the first point of contact for global compliance challenges and build key partnerships and collaborate with the different (global & local) quality functions and the TR&D stakeholders.
  • Support the local stakeholders for continuous improvement of the global as well as their local quality system and processes, e.g. by sharing Best-Practices.
  • Interpret global, company-wide GMP systems/business processes to apply to the development pipeline. 
  • Interpret global regulatory requirements relative to the global clinical quality system development and maintenance.
  • Maintain awareness of new regulations (e.g. ICH) and monitor emerging regulatory trends to assess impact on the clinical quality systems and the business and evaluate impact to established Quality Systems.
  • Evaluate existing systems for monitoring compliance and effectiveness of IMP quality systems and business processes. 
  • Revise as necessary to ensure continuous improvement.
  • Build key partnerships and collaborate with corporate quality, site quality, and stakeholders to ensure the achievement of goals.
  • Perform other related duties (as defined by IMP Quality Systems management) that may be required based on corporate, PTD, IMP Quality goals and business needs.
  • Be the first point of contact for global compliance challenges and build key partnerships and collaborate with the different (global & local) quality functions and the TR&D stakeholders.
  • Support the local stakeholders for continuous improvement of the global as well as their local quality system and processes, e.g. by sharing Best-Practices.
  • Ensure our stakeholder awareness of new regulations and regulatory trends for IMPs and support the implementation of it.

Summary of Qualifications:
  • B.S. or B.A. degree (preferably in relevant scientific discipline) and at least ten years relevant business and/or technical experience in the pharmaceutical or biopharmaceutical industry preferably in clinical (IMP) development.   
  • Advanced degree desirable.
  • Current working knowledge of cGMPs, ICH guidances, and regulatory and industry technical standards relative to clinical (IMP) development.  
  • Understanding of international GMPs, regulations and standards is a plus.
  • Previous experience with development of quality standards and processes.
  • Proven track record of successfully planning, implementing, and tracking of global/highly complex projects on time and within budget.
  • Lean six sigma, operational excellence, process mapping/improvement experience desired
  • Strong collaboration skills across cultures, countries, and organizational levels
  • Excellent communication (verbal and written), interpersonal and organizational skills are essential. 
  • Some (5-10%) travel required (will vary based on projects/role).

Erik Cordova

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