Senior Manager Quality Assurance and Regulatory Affairs
Vor 3 Tagen
This position is a safeguard and role model for the Wu Xi values and competencies. As a key member of the Quality Leadership Team, the successful candidate will be responsible for ensuring the entire Couvet site operates in compliance with regulatory requirements and company policies.
Key Responsibilities- Act as the deputy of the Responsible Person (RP) according to Art. 5 and Art. 17 of the Swiss Ordinance on Establishment Licenses (SR) and of the Qualified Person according to Annex 16 of the EU Guide to Good Manufacturing Practice for Couvet site.
- Act within the site's key projects teams as the main Quality representative and single point of contact for QA, Compliance, Quality Supplier, and Regulatory Affairs.
- Coordinate and drive quality activities related to technology transfer, analytical tech transfer, raw materials introduction, supplier qualification, manufacturing specifications, and CMC dossier setup.
- Conduct assessments of change controls for site-related projects and/or for product life-cycle projects with relevant quality SMEs and act as the site interface with Global Regulatory (CMC & Affairs).
- Support responses related to regulatory authorities' requests, e.g., in the scope of submission or periodic GMP review, as well as review of regulatory authorities' citations provided to other sites.
- Actively support site Quality activities such as multi-site investigations, drive change controls upon requests, review of MBR and executed batch records related to NPI, internal audits (as auditor), health authority and client inspections, continuous improvement, and ensures compliance to the policy of security at work and to laws concerning health and security of the workers within the area of responsibility.
- At least 7 years of experience in Quality Assurance, Quality Control, and/or Regulatory Affairs in a pharmaceutical company or other related industry.
- Bachelor's degree in Pharmacy, Chemistry, Microbiology, or related science.
- Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
- Demonstrated experience in Regulatory strategies and tactics.
- Strong knowledge of all phases from the global drug development process and clinical trial data flow up to analytical/technology transfer to manufacturing/testing site and product launches.
- Solid understanding of Oral Solid Dosage form manufacturing, packaging, testing, warehousing processes, validation, and registration.
- Strategic thinking, business acumen, holistic approach, leading vision, innovation management, and negotiation.
- Ability to transfer strategies to tactical execution.
- Excellent interpersonal, collaborative, and organizational skills.
- Strong communication skills.
- Ability to communicate effectively to management, functional groups, broader organization, and executives.
- High credibility and reliability.
- Excellent investigational and QA problem-solving skills.
- Ability to interpret complex situations with a degree of independence and to articulate recommendations for resolution.
- Drives continuous improvement.
- Knowledge of most common office software and of IT-principles.
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Colombier NE, Neuenburg, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the Wu Xi values and competencies. As a key member of the Quality Leadership Team, you will play a critical role in ensuring the quality and compliance of our products and processes.The successful candidate will have a strong understanding of cGMPs and regulatory requirements, as well as experience...
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Colombier NE, Neuenburg, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a safeguard and role model for the Wu Xi values and competencies. As a key member of the Quality Leadership Team, the successful candidate will be responsible for ensuring the entire Couvet site operates in compliance with regulatory requirements and company policies.The position holder will act as the deputy of the Responsible...
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