Quality Manager, Commercial Quality Europe

vor 7 Monaten

Basel, Schweiz BeiGene Vollzeit

General Description:
The incumbent will report to the Head Commercial Quality Europe and will be responsible for supporting activities relating to BeiGene’s external GMP operations in Europe and as well as internal BeiGene GMP processes, ensuring procedures and systems are in place to support BeiGene’s commercial products.

The incumbent will support that commercial products are manufactured, packed, labelled, distributed, and controlled in accordance with regulatory expectations and applicable quality standards.

Essential Functions of the job:

- Provide Quality oversight of external GxP operations, e.g. drive, lead and troubleshoot quality investigations at external partners to ensure that all major quality issues are thoroughly investigated with appropriate corrective actions.
- Batch Record review, release preparation and batch disposition of commercial APIs, primary packed products and finished products manufactured by contract manufacturers on behalf of BeiGene.
- Close collaboration with BeiGene's Manufacturing, Supply Chain, and Regulatory CMC project teams.
- Close collaboration with EU Qualified Persons to ensure compliance with legislative requirements as provided by Directive 2001/83/EC and Directive 2001/82/EC and MRA.
- Ensure GxP partners (i.e. CMOs, Distributors, etc.) are compliant for regulatory inspections and monitor progress during inspections.
- Take ownership of issues and collaborate with Supply Chain, Regulatory Affairs, etc., to drive issues to full resolution for global and EU stakeholders.
- Support continuous improvements of internal and external related processes.
- Support Quality Agreement implementation and updates.
- Support Quality meetings between CMOs, partners, and BeiGene.
- Monitor performance metrics and support Quality Management Reviews.
- Involvement the development of training materials and/or programs regarding all aspects of producing quality products.
- Provide regular updates to management on assigned project progress and escalate challenges as needed.
- Support quality projects
- Support or drive SOP updates,
- Support internal audit and Health Authority inspection preparation and execution
- Perform other support tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelines
- Schedule, track, and assist with running of meetings; create meeting summaries
- This is a hands-on position.

Education Required:

- Bachelor’s degree in science or combination of education and equivalent work experience

**Experience**:

- Min 2-6 years pharmaceutical or biotechnology industry experience.
- In-depth GMP experience in a quality and manufacturing function.
- Worked in an area with commercial QA experience as an asset.

Core Knowledge and Skill Requirements:

- In-depth knowledge of Quality principles, concepts, industry practices and standards.
- Working Knowledge and experience with EudraLex EU GMP Guidance, 21CFR210, 21CFR211, ICHQ7 as well as international regulations.
- Follow internal Global Standard to support temperature excursion handling
- Excellent verbal, written and interpersonal communication skills.
- Ability to work independently with scientific/technical personnel.
- Experience with regulatory compliance inspections.
- Must possess good presentation skills to speak effectively before groups; ability to respond.
- Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail.
- Experienced with working cross-regions Supply Chain, Regulatory, and external service providers
- Spoken/Written fluency in English required
- Spoken/Written fluency in German/French preferred

Computer Skills:

- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
- Ability to work on a computer for extended periods of time

Other Qualifications:

- Good Project Management Skill Set

Travel:

- May travel approximately 5 - 10%

Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected even

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