BeOne is experiencing rapid growth and requires experienced professionals to manage and implement Compliance programs for their Hopewell, NJ site, supporting both clinical and commercial manufacturing.
Requirements
- Subject matter expert in GMPs: 21 CFR 210, 211, and 600; knowledgeable in EU Advanced Therapy Medicinal Products (ATMPs).
- Deep knowledge in pharmaceutical QMS.
- Demonstrable track record and skills/experience gained within a similar position(s), at a similar level, specifically pertaining to vendor qualification, leading vendor audit programs, and vendor performance management.
- Wide knowledge of products and processes used in the manufacture of clinical and commercial manufacturing processes.
- Knowledge of both large and small molecules.
- Strong analytical and problem-solving ability.
- Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP.
Responsibilities
- Within the Quality Assurance organization, develop and implement Compliance programs for the Hopewell, NJ Site.
- Determining the appropriate quality KPI’s for clinical and commercial operations.
- Working with vendors on as needed for Quality Assurance Agreement authoring and vendor qualification.
- Development of all necessary SOPs, ensuring regulatory compliance in conjunction with being appropriate both clinical and commercial operations.
- Ensuring that all activities are performed in accordance with GMP, SOPs and Health and Safety policies.
- Ensuring the availability of adequate competent resources to execute these QMS programs for commercial and clinical products.
- Developing a program for Deviation Management Excellence.
Other
- Minimum of 5 years of experience in people management.
- Strong personal leadership, ability to lead small teams.
- Good communicator (written and verbal) and strategic thinker, highly customer focused.
- Hands-on approach, with a ‘can do’ attitude.
- Must be willing to travel approximately 10% as needed.
