QA Auditor Compliance Manager
Main Responsibilities:
* Ensure compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) regulations at third-party service providers and internal facilities.
* Develop and lead the implementation of external quality audit and internal self-inspection annual plans.
* Conduct regular GMP/GDP audits and self-inspections, coordinating with internal personnel and suppliers to schedule, execute, and follow up on audit observations.
* Promptly report critical self-inspection findings to management.
* Create, implement, maintain, and collaborate with vendors to establish Quality Agreements as needed.
* Facilitate communication between quality/regulatory/compliance teams and operations to identify applicable regulatory requirements and ensure accurate understanding of those requirements.
* Oversee, review, and approve change controls, deviations, and corrective actions related to internal pharmaceutical operations facilities.
* Develop, review, and approve internal standard operating procedures (SOPs) governing compliance-related operations and other GMP/GDP documentation.
* Provide quality oversight for equipment qualification, calibration, and validation.
* Support preparation for regulatory authority inspections.
* Maintain awareness of changes in quality regulations and initiate necessary activities to ensure compliance of the quality system.
* Support optimization of the quality system by collaborating with cross-functional teams to gather key performance indicators and participating in Quality Management Review (QMR) meetings to communicate these metrics.
* Foster a Good eXchange Practice (GxP) and quality mindset throughout the organization.
* Travel may be required (up to 30%), including international travel.
Qualifications and Experience:
* Eligibility for Swiss working/residency permit and/or Swiss/EU citizenship is required.
* Bachelor's degree in Pharmacy, Chemistry, or a related technical/science field; master's degree minimum.
* A minimum of three years' experience in auditing, with one year as Lead Auditor.
* Proficiency in drug product development, manufacturing processes, quality control, packaging, and distribution aspects.
* Excellent knowledge of relevant GMP/GDP and international quality regulations, such as ICH, ISO, WHO, PIC, FDA, EU GMP Guide, EU GDP, and ability to interpret and implement quality standards.
* Ability to manage multiple projects, work effectively with diverse disciplines, and prioritize tasks according to project importance.
* Attention to detail, organizational skills, multitasking, and comfort interacting with people at various levels.
* Proactive initiation and leadership of quality compliance activities.
* Self-confidence, assertiveness, and autonomy to handle complex situations and stakeholders.
* Strong interpersonal and influencing skills.
* Fluent verbal and written communication skills in English, with basic knowledge of an additional European language (e.g., German or French).
* Experience in Medical Devices is advantageous.