Quality Lead

**Job Title: Quality Lead (CMO)**

**The company**

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. Our clients are driven to continuously innovate and create meaningful value in all they do to help patients and families fully live their best lives. They value the uniqueness and diversity of employees and recognize that nurturing the diverse perspectives and strengths of the workforce translates into innovative breakthroughs for patients.

They provide an atmosphere that supports employee’s ambitions, values integrity, encourages respect, relationships and teamwork, with adequate supports to solve work-related challenges.

**RESPONSIBILITIES**:

- 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 product stage in focus is Label and Pack activities for originator products.
- 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, artworks and support to asset functions such as review and approval of regulatory filings.
- The CMO Quality lead is the company's point of contact with key/critical CMOs, establishing the appropriate relationship and is a member of the internal Virtual Plan team.

**JOB SPECIFICATION**:

- 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 SME
- Collaborate actively with key/critical 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.
- Collect Key Process Indicators and Identify appropriate actions in collaboration with CMO up to successful implementation
- Contribute to Regulatory inspection including needs of Biogen presence, review of observations, responses and action plan follow-up
- Prepare and Manage Quality Management Review, Annual Product Review performance and Quality agreement
- Support recall management.
- Identify and drive improvements/updates of the GMP documentation related to QE activities
- Identify any compliance gap in Biogen processes and identify appropriate stakeholder to fix the issue
- Support local Quality system (change control, deviations, CAPAs,) as required.
- Ensure adherence to serialization and data integrity requirements.

**EXPERIENCE**:

- 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, knowledge of Japanese or other geographies’ regulations is a plus);
- Knowledge of medical device regulations and unit operations for manufacturing of either parenterals or pharmaceuticals, is a plus.
- Experience in project management and ability to develop effective working relationships with internal/external sites and cross-functional project teams.

**QUALIFICATION**:
Minimum Bachelor's degree, Master degree preferred, in a scientific

topic (Pharmacy, Chemistry, Biology, Biochemistry etc).

**SKILLS**:

- Strong communication skills.
- Ability to work in an international matrix environment.
- Negotiation skills.
- Ability to clearly articulate complex situation into resolution by providing path forward to the upper management.

**Job Types**: Full-time, Temporary / Staffing
Contract length: 9 months

Pay: Up to CHF115,000.00 per year

**Benefits**:

- Free parking
Schedule:

- 8 Hour Shift
Expected Start Date: 30/08/2021