Job Title: Project Manager - Product Development Quality
Job Function: Project Management
Therapy Area/Industry: Pharmaceutical Quality Assurance
Job Description:
Proclinical is seeking a Project Manager to oversee the quality assurance processes related to the manufacture, testing, and distribution of clinical supplies. This role focuses on ensuring compliance with Good Manufacturing Practice (GMP) and involves collaboration with various teams to manage the release of clinical supplies from Contract Manufacturing Organisations (CMOs). You will play a crucial role in aligning project priorities and ensuring timely delivery of health authority approvals.
Responsibilities:
- Manage and support the External Qualified Person (QP) release process.
- Coordinate and align all necessary documentation.
- Address QP-related queries effectively.
- Collaborate with Trial Supplies Management, Trial Managers, Regulatory CMC QA, Regulatory Affairs, and Product Development Quality teams.
- Identify dependencies, evaluate risks, and communicate project status to management and stakeholders.
- Ensure project deliverables and schedules are met according to established standards.
- Proactively remove obstacles to maintain project momentum.
- Plan and engage resources to ensure successful project completion.
- Apply and advise on Project Management best practices and tools.
Key Skills and Requirements:
- Degree or equivalent experience.
- Essential experience in Project Management.
- Preferred experience in Pharmaceutical Quality.
- Proven ability in leading continuous improvement initiatives.
- Strong relationship-building skills with a focus on diplomacy.
- Experience in process improvement.
- Ability to assess internal/external challenges impacting future success.
- Proficient in computer systems (MS Excel, Word, etc.).
- Capable of coordinating and leading meetings.
- Knowledge of clinical trial documentation submission and approval is preferred.
Please apply on Linkedin.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. Proclinical Staffing is an equal opportunity employer.