Senior Regulatory Compliance Specialist

Job Title: Expert GMP Auditor

Key Responsibilities:

• Contribute to the establishment of a strategic audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.
• Plan, lead, conduct, document, and follow-up audits according to quality procedures and applicable regulations, standards, agreements, and guidance documents.
• As an expert leader, you will be able to audit complex and high-risk sites and activities. You are considered an expert in one or more manufacturing areas, such as sterile manufacturing, combination products, biologics, etc.
• Provide technical guidance, mentoring, and training on audit activities.
• Offer regulatory guidance for timely remediation and recommendations regarding acceptability of proposed filings.
• Prepare audit reports according to required timelines.
• Educate stakeholders on appropriate escalation procedures in case of critical findings and support immediate follow-up measures according to established requirements.
• Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with stakeholder QA representatives and auditees.
• Act as a GMP compliance consultant for trainings, task forces, continuous improvement projects as needed.
• Review and advise on relevant policies and procedures.
• Mentor junior staff members as required. Ability to perform training for non-certified and junior staff.
• Maintain current knowledge of regulations and develop best practices auditing guidelines. Support development/training of GMP auditors.
• Support commitments and global initiatives as outcomes of inspection findings.

Essential Requirements:

• At least 15 years of experience in Pharmaceutical or Medical Device Industry.
• The operational experience should include QA/QC management and manufacturing, or development, or other relevant experience, e.g., working at a regulatory health authority.
• At least 3+ years of auditing experience, and excellent knowledge of regulatory requirements. Willingness to travel approximately 60% of the time.
• Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems.
• Experience and/or interaction with local Health Authority and sporadically with other Health Authorities.
• Excellent interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with colleagues, vendors, and customers. The Associate must be able to effectively represent the department both internally and externally.
• Sound and practical judgement in the interpretation and application of regulations and standards.
• Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision.
• Excellent leadership and facilitation skills.

Desirable Requirements:

• Degree in Chemistry, Pharmacy, Biology, Engineering, or another related science.
• Excellent oral and written English communication skills. Preferable: Good knowledge/mother tongue of an additional language (e.g., German, French, Italian, Chinese, or Spanish).

Skills Desired:

Agility, Auditing, Business Acumen, Business Partnering, Business Strategy, Collaboration / Teamwork, Communication Skills, Compliance Audits, Continuous Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Finance Acumen, Gmp Procedures, Goal-Oriented, Health Authorities, Leadership, Logical Thinking, Major Incident Management, People Management, Problem Solving Skill, Qa (Quality Assurance), Self-Awareness