Global QA/ra Manager

vor 3 Wochen


Zurich, Schweiz Barrington James Vollzeit

Zürich District
- 10-05-2023
- JOB TYPE
- Permanent
- EMP TYPE
- Full-Time
- EXPERTISE
- CMC
- SALARY TYPE
- Annually
- SALARY
- Negotiable

Are you a highly skilled and experienced Quality Assurance and Regulatory Affairs professional with a specialisation in Chemistry, Manufacturing, and Controls (CMC) within the pharmaceutical industry? Are you passionate about ensuring the highest standards of quality and compliance in pharmaceutical manufacturing? If so, we have an exciting opportunity for you to join our team as Quality Assurance and Regulatory Affairs Manager.

**Responsibilities**:
Develop and implement quality systems and processes in accordance with regulatory requirements, industry standards, and best practices, with a specific focus on CMC in pharmaceuticals.

Collaborate cross-functionally with internal teams, including Research and Development, Manufacturing, and Regulatory Affairs, to ensure compliance with CMC requirements and support the development and commercialization of pharmaceutical products.

Serve as the primary contact for regulatory agencies, actively participating in regulatory inspections and audits related to CMC in pharmaceuticals.

Stay abreast of regulatory guidelines and industry trends related to CMC in pharmaceuticals, proactively communicating relevant updates to internal stakeholders.

Conduct internal audits and oversee external audits to ensure compliance with regulations and standards.

Implement and maintain an effective document control system for CMC-related documentation.

Qualifications:
Bachelor's or Master's degree in Pharmacy, Chemistry, or a related scientific discipline.

A minimum of 10 years of experience in Quality Assurance and Regulatory Affairs, specialising in CMC within the pharmaceutical industry.

In-depth knowledge of regulatory requirements and guidelines related to CMC, including FDA, EMA, and ICH guidelines.

Strong understanding of the drug development process, from research and development to commercialisation, within the pharmaceutical industry.

Proven track record of successfully managing CMC-related submissions and interactions with regulatory agencies in the pharmaceutical industry.

Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and regulatory authorities.

Strong analytical and problem-solving abilities, with keen attention to detail.

Experience with quality management systems and tools within the pharmaceutical industry.

Professional certifications related to quality assurance and regulatory affairs are a plus.

Consultant
- Julian Marriage
- +441293776644


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