Assistant Project Manager
Roche
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. You will work in an atmosphere of openness and trust, leveraging your communication skills to manage vital documents that directly impact our strategic healthcare goals.
Job description
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 the process validation area
- 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
- Highly motivated self-starter
- Ability to handle multiple priorities, conflicts, and ambiguity
- Preferred: hands-on experience authoring and/or editing process validation documentation
Benefits
- Discretionary annual bonus
- Health benefits
Company overview
Roche is a Swiss multinational healthcare company and a global pioneer in pharmaceuticals and diagnostics, founded in 1896 and headquartered in Basel, Switzerland. As the world's largest biotech company and the fifth-largest pharmaceutical company by revenue, Roche operates through two primary divisions: Pharmaceuticals and Diagnostics. The company is renowned for its leadership in personalized healthcare, combining strengths in both drug development and diagnostic testing to deliver tailored treatments for patients. Roche maintains a strong focus on oncology, immunology, infectious diseases, ophthalmology, and central nervous system disorders, with a portfolio that includes over 30 medicines on the World Health Organization's Model Lists of Essential Medicines. The company owns significant subsidiaries including Genentech, Chugai Pharmaceuticals, Ventana Medical Systems, and Foundation Medicine. With approximately 103,000 employees worldwide and operations in over 100 countries, Roche has established itself as a leader in cancer treatments globally while maintaining a robust pipeline of innovative therapies and diagnostic solutions. The company's commitment to sustainability has been recognized through ten consecutive years as Group Leader in the Dow Jones Sustainability Indices within the Pharmaceuticals, Biotechnology & Life Sciences Industry.