Principal Project Manager

Vacaville, CA 95688

Posted: 05/24/2019 Employment Type: Contract Industry: Clinical & Scientific Job Number: 15782

Bayside Solutions is seeking a Principal Project Manager to be part of our client’ s team in Vacaville. 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.

Principal Project Manager

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:
  • Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
  • Use (and create and implement, if necessary) local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices.
  • Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
  • Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate.
  • Ensure compliance of training to PQS and job-related requirements.
  • Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
  • Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
  • Participate in hazards analyses and design assessments and reviews.
  • Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.
  • Development & implementation of Device Team execution plans
  • Lead large cross-functional teams/committees to achieve goals and/or represent PMO on interdepartmental teams to develop, implement and drive PM best practices 
  • Goal setting and performance management for direct reports

Summary of Qualifications:
  • MA/MS + a minimum of 12 years total work experience with at least 8 or more year’ s relevant business and/or technical experience in the medical device, pharmaceutical or biopharmaceutical industry preferably from a multi-site global company.  Experience in combination products considered an asset.
  • At least 8 years Project Management experience - PMP certification considered an asset
  • Proven track record leading development projects and an in depth knowledge to apply project management methodologies and Design Control requirements.
  • Expertise in the drug development process - demonstrated practical experience and knowledge of medical device development and commercialization
  • Knowledge of relevant regulatory and Health Authority  requirements and expectations applicable to drug development and design control requirements
  • Demonstrated proficiency with Google, Microsoft Office, WebEx, Visio software tools
  • Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, ever-changing, team-based environment.
  • Excellent written and verbal communication, listening, negotiation, presentation, organizational and relationship-building skills required. Must be able to effectively communicate and align plans with external party as applicable
  • Onsite 5 days per week - Some travel expected dependent on project assignment

Ethan Christenson
Scientific Recruiter

If you are looking for career growth or new opportunities you have come to the right place! Here at Bayside solutions we specialize in relationship based recruiting, we are focused and determined to take your career in the direction you want it to go. I would love to talk to you about your career objectives, sports, traveling, or anything else that interests you. I look forward to getting to know you and where you want to go!
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