Project Manager II
1000 New Horizons Way Vacaville, CA 95688
Bayside Solutions is seeking a Project Manager II 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.
Project Manager II
- 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.
- The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization.
- Manage moderate scale teams and projects of increased complexity.
- Develop realistic project plan/schedules.
- Define, oversee and track Development Team' s progress in meeting milestones and deliverables.
- Partner closely with Device Team Leader (DTL) to define and execute the device/technology strategy and facilitate team meetings with key stakeholders to drive sharing of information, efficient decision-making, issues resolution, risk mitigation and team member engagement.
- Ensure device/technology strategy is integrated with Technical Development Team (TDT) plan and aligns with overall Lifecycle Team (LCT) strategy.
- Analyze and understand the critical path activities and ensure team members are aware of the interdependencies.
- Connect with management to provide regular project updates on project status including risk mitigation plans and to escalate unexpected events impacting project schedule, budget and resources.
- Monitor resource and project variable costs needed to execute Plan and work closely with TDT project manager to ensure budget is integrated with TDT plan in PlanSource.
- Support relevant design control activities and assist with drafting, compilation and tracking of Design Control documentation as required.
- Support business process improvement efforts (e.g. updating business process content, implementing tools and best practices, and driving awareness across Teams.)
- Maintain knowledge of system performance at sites and business units, through familiarity with local SOPs, frequent interactions with local system owners, and established performance metrics.
- Be accountable for behaviors described in Genentech’ s Core, Common and Critical Competencies.
- Enroll in required training based on business/project need.
- Flexible in problem solving, providing direction and work hours to meet business objectives.
Summary of Qualifications:
- B.S., B.A or advanced degree, preferably in Chemistry or Biochemistry, or the equivalent.
- At least 5 (7 in Job description) years of relevant business or technical experience in the industry, preferably a multi-site global company in the medical device, pharmaceutical or biopharmaceutical, after receiving their Bachelors degree
- Experience in combination products is highly desirable. Expertise in the drug development process is expected; need to have demonstrated practical experience and knowledge of medical device development and commercialization. Ability to integrate science, drug and device development knowledge and regulatory expectations to execute project plans.
- Application of relevant skills, tools and requirements
- Project Management: Project planning, scheduling, tracking team deliverables and actions, facilitating team decisions, risk management, resource and cost forecasting, meeting management, regular project status communication, PMP certification
- Software tools: Google, Microsoft Office, WebEx, Visio, Project
- Requirements: International standards (e.g. ISO 13485), federal regulatory compliances (e.g. FDA and EU), filings, relevant health authority regulations, Drug Development processes, Design Controls, GDP/GLP/GMP, Design History Files
- Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast-paced, ever-changing, team-based environment.
- Excellent oral and written communication skills (listening, negotiation, presentation, organizational and relationship-building, etc) are required.
- Highly organized and detail oriented.
- Must be able to effectively communicate and align plans in a highly matrix organization and with external party as applicable.