Senior Quality Manager - cGMP

06 Dec 2018
13 Dec 2018
MC 23862
Quality, QA / QC
Contract Type
An excellent opportunity has arisen to join a leading pharmaceutical company as a Senior Quality Manager.
Provide QA oversight on all external suppliers for Biologics Drug Substance Supply. Manage supplier qualifications, supplier changes, and quality agreements. Assure compliance to cGMP standards is maintained for third party management.

• Responsible for initiating and driving supplier qualifications
• Upgrade of supplier qualifications from clinical to commercial in scope of the commercial project
• Upgrade of raw materials and consumables from clinical to commercial in scope of the commercial project
• Oversight on all suppliers and raw materials used
• Manage quality aspects at external suppliers and ensure their compliance with good manufacturing practice
• Manage and evaluate change notifications from external suppliers
• Write GMP relevant documents in area of responsibility (SOPs, Quality Agreement, APS) and ensure implementation at third parties
• Perform local implementation of Novartis Quality Manual and global procedures (gap assessment, local changes in SOPs...)
• Manage projects, and provide QA support. May provide functional expertise in area of responsibility (supplier qualification).
• Represent BTDM BDSS Quality in initiatives. Liaise with key stakeholders
• Lead project related activities (e.g. development of new tools and processes).
• Provide support line functions in GMP compliance related issues in area of expertise.
• Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans.
• Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidances, SOPs, HSE, etc). Promote and enforce compliance to guidelines.

Job Description

• Supplier oversight and supplier approval rate
• In accordance with objectives such as support of projects with agreed quality and delivery date, passing of internal and external inspections.
• Act in accordance with Novartis standards, in particular ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
• Maintain sound working relationships with partners and customers.
• Feedback from other team members
• Meet quality and timelines in all projects

• Education:
o Minimum: Basic degree in scientific or relevant discipline (BS or equivalent)
o Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)

• Languages:
o Fluent in English (oral and written) required; fluent in site-language desirable

• Experience/Professional requirement:
o At least 3 years of relevant experience.
o Strong ability to negotiate and communicate.
o Good team working skills
o Sound scientific, technical and regulatory knowledge.
o Excellent knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines.
o Good knowledge of drug development and drug substance production.
o Good organizational skills.
o Good and proven ability to analyze and evaluate GMP compliance.

Key People is a specialist international recruitment consultancy with over 25 years’ experience of working within the life sciences, biotech, healthcare and CRO industries. Our experienced and dedicated clinical research related consultants have a long history of success, excellent technical knowledge and a flexible, consultative focussed approach to recruitment.

Please contact Mark Cussens, Clinical Research Recruiter on
Tel: +44 1727 817623 or email:
Tel: +41 4350 86620 or email:

Key People is a recruitment company with a reputation for providing good value that’s been built up over 20 years.
- We achieve results faster
- Our candidates really are a cut above
- We add greater value
We think it’s because we’re a private company driven by clients, not by shareholders.

For our candidates, we have developed relationships with thousands of clients nationwide and across Europe, who choose to recruit through Key People, so you’ll have a wide choice of opportunities to further your career.

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