Quality Assurance Compliance Manager

vor 16 Stunden

Basel, Schweiz Apsida Life Science Vollzeit

Apsida Life Science is looking for a QA Compliance Manager.

Key Responsibilities:

  • Ensure compliance with GMP standards at both third-party service providers and internal facilities.
  • Develop and assist with the annual plan for external QA audits and internal self-inspections.
  • Conduct GMP/GDP audits and self-inspections, coordinating with internal teams and suppliers to schedule, execute, and follow up on audit findings.
  • Report critical self-inspection findings promptly to the Responsible Person and Management.
  • Create, implement, and maintain Quality Agreements with vendors as needed.
  • Act as a liaison between quality/regulatory/compliance personnel and operations to identify and ensure understanding of regulatory and compliance requirements.
  • Manage, review, and approve change controls, deviations, and CAPAs related to internal pharmaceutical operations (not project-specific).
  • Write, review, and approve internal SOPs related to compliance operations and other GMP/GDP and regulatory documentation.
  • Provide quality oversight for equipment qualification, calibration, and validation.
  • Support the preparation for Regulatory Authority Inspections.
  • Collaborate with cross-functional teams to optimise the pharmaceutical quality system, gather key performance indicators, and support Quality Management Review (QMR) meetings.
  • Promote a GxP and Quality mindset throughout the organization.
  • Travel may be required (20%-30%), including international travel.

Candidate Requirements:

  • University degree in Pharmacy, Chemistry, or a related technical/science field (master's level minimum).
  • At least 3 years of auditing experience, with a minimum of 1 year as a Lead Auditor.
  • Knowledge of drug product development, manufacturing processes, quality control, packaging, and distribution.
  • Excellent understanding of GMP/GDP and international quality regulations (e.g., ICH, ISO, WHO, PIC, FDA, EU GMP Guide, EU GDP) and the ability to interpret and implement quality standards.
  • Strong attention to detail, organizational skills, and the ability to interact with individuals at various levels.
  • Proactive in initiating and leading quality compliance activities.
  • Self-confident, assertive, and capable of handling complex stakeholders and situations.
  • Fluent in English, with at least basic knowledge of an additional European language (e.g., German or French).
Seniority Level

Mid-Senior level

Employment Type

Contract

Job Function

Engineering, Quality Assurance, and Manufacturing

Industries

Staffing and Recruiting, Pharmaceutical Manufacturing, and Environmental Quality Programs

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