Assistant Project Manager
Genentech
Summary
As a Process Validation Coordinator, you are joining a dedicated technical project team focused on ensuring the highest quality standards for critical health authority submissions. This role offers a unique opportunity to cultivate strong collaborative relationships while driving process improvements and compliance across multiple departments.
Job description
The Position
As a Process Validation Coordinator, you are joining a dedicated technical project team focused on ensuring the highest quality standards for critical health authority submissions. This role offers a unique opportunity to cultivate strong collaborative relationships while driving process improvements and compliance across multiple departments.
The Opportunity
- Coordinate assigned Process Validation (PV) study documents for projects and support vital Health Authority submissions.
- Proofread, edit, and compile supporting data for PV protocols and reports to ensure accuracy, completeness, and consistency.
- Coordinate the adjudication of reviewers' comments with authors and Subject Matter Experts (SMEs), providing timely follow-ups to outstanding queries.
- Perform compliance reviews of completed PV work to guarantee strict alignment with internal Quality standards and requirements.
- Facilitate PV template creation and assist in training cross-functional teams on workflows, timelines, and compliance requirements.
- Communicate effectively with cross-functional project teams, present PV activities at department meetings, and resolve conflicts in a positive manner.
- Utilize appropriate IT solutions and tools to manage process knowledge and gather key technical information to keep systems updated.
Who You Are
- Hold a Bachelor's degree or higher and have 0-2 years of relevant work experience in the process validation area.
- Experienced with process validation documentation requirements and possess excellent business acumen and solid judgment to work autonomously.
- Strong communicator with interpersonal skills to establish collaborative relationships, resolve conflicts positively, and influence without authority.
- Highly motivated self-starter with strong project management skills to consistently achieve multiple tasks on time.
- Highly adaptable and capable of handling multiple priorities, conflicts, and ambiguity effectively.
Preferred
- Hands-on experience authoring and/or editing process validation documentation.
Requirements
- Bachelor's degree or higher
- 0-2 years of relevant work experience in process validation
- Experience with process validation documentation requirements
- Excellent business acumen and solid judgment to work autonomously
- Strong communication and interpersonal skills
- Ability to establish collaborative relationships and resolve conflicts positively
- Ability to influence without authority
- Strong project management skills
- Ability to handle multiple priorities, conflicts, and ambiguity
Benefits
- Discretionary annual bonus
- Health benefits
Company overview
Genentech, founded in 1976 and now a member of the Roche Group, is widely recognized as the pioneer of the biotechnology industry. The company has been at the forefront of scientific innovation for nearly 50 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech's transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. With over 10,000 employees, the company operates from its South San Francisco headquarters and maintains a strong focus on oncology, immunology, neuroscience, ophthalmology, and infectious diseases. Genentech continues to pursue groundbreaking science while maintaining its startup spirit within the Roche organization, consistently delivering on its promise to improve patients' lives through innovative biopharmaceutical solutions.