Cmo Quality Lead

**Job Description**:
**About This Role**

The main purpose of this job is to manage the Quality Activities with key/preferred manufacturing and testing partners (CMOs) for assigned products/projects by ensuring quality of product / process transfers, validations, issues investigations, tracking and resolution in a timely manner as well as process improvements.

The responsibilities also include the evaluation of the performance of contractors and the identification, negotiation, implementation and follow-up of process and systems improvements. The role also includes quality management of the product lifecycle management in relation with contract manufacturing and support to asset functions such as review and approval of regulatory filings.

The CMO Quality lead is the Biogen point of contact with key/critical CMOs, establishing the appropriate relationship and is a member of the internal Virtual Plan team..

**What You’ll Do**

**1. **CMO Oversight**
- Quality Operations activities management with key/critical CMOs
- Ensure appropriate corrective and preventive actions are defined, implemented and that their effectiveness is assessed.
- Develop knowledge of the manufacturing line at key/critical contract organizations (CMOs) and provide technical support for the manufacture of product, in collaboration with SMEs
- Prepare and manage Quality Management Review, Annual Product Review performance and Quality Agreements
- Collaborate actively with key CMO to sustain without disruption the supply chain
- Ensure that the CMOs maintain quality systems that are in the state of compliance and aligned with Biogen expectations
- Participate to technology transfer, scale-up or improvements projects through validation and on-site presence

**2. **Quality System**
- Identify and drive improvements/updates of the GMP documentation related to QE activities

**3. **Communication & Build Strategic Work relationship**
- Identify and timely communicate to the management any supply risk or risk of batch rejection
- Able to clearly communicate expectations to internal/external customers as well as management or peers

**4. **Decision Making**
- Solve technical and operational problems in field of expertise based on existing policies, procedures and solutions. Makes operational decisions within scope and accepts full accountability of decisions made, but also recognize when to escalate.
- Prepare and present information contributing to reject/recall decisions

**Qualifications**:
**Required Skills**:

- Minimum Bachelor's degree in a scientific field (Pharmacy, Chemistry, Biology, Biochemistry etc.)
- A minimum of 5 years of experience in pharmaceutical or biotechnology industries
- Relevant experience in either manufacturing, development, quality or regulatory; Understanding of cGXPs, quality systems and regulations (FDA and EU mainly)
- Experience in project management and ability to develop effective working relationships with internal/external sites and cross-functional project teams
- Solid experience in CMO management
- Ability to clearly articulate complex situation into resolution by providing path forward to the upper management
- English fluent

**Preferred Skills**
- Master degree in a scientific field
- Knowledge of medical device regulations and unit operations for manufacturing of parenterals, is a plus
- Strong communication skills
- Ability to work in an international matrix environments
- Negotiation skills
- Ability to clearly articulate complex situation into resolution by providing path forward to the upper management

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.