About Amtera: Amtera is a consultancy firm specializing in engineering, technology, and compliance. Our mission is to foster advancement in these fields and provide innovative solutions to our clients across a wide range of sectors, including Biopharma, Pharmaceutical, Chemical, FMCG, Medical Devices, as well as Energy, Banking, and Insurance. At Amtera, we are dedicated to excellence and thrive on delivering impactful results through cutting-edge technology and engineering practices.
Position Overview: We are seeking a highly skilled and experienced Compliance Manager to join our team for a pharmaceutical client in the Basel region. The primary focus of this role is to advise the client on preparing for FDA audits, ensuring compliance with all relevant pharmaceutical industry standards and FDA regulations. The ideal candidate will have a strong background in compliance management within the pharmaceutical sector and extensive experience with FDA audit readiness.
Key Responsibilities:
- Advise the client on strategies and best practices for FDA audit preparation, ensuring all aspects of the operation meet regulatory standards.
- Develop and implement compliance programs that align with GMP, FDA, EMA, ICH, and other relevant industry standards and guidelines.
- Conduct gap analyses to identify areas of non-compliance and develop action plans to address deficiencies.
- Prepare and review documentation, including SOPs, validation protocols, and quality management systems, to ensure FDA audit readiness.
- Conduct internal audits and mock FDA inspections to evaluate the client’s compliance status and readiness for official audits.
- Provide training and support to client personnel on compliance requirements, FDA audit processes, and industry standards.
- Monitor regulatory changes and updates, advising the client on necessary adjustments to maintain compliance.
- Collaborate with cross-functional teams, including quality assurance, regulatory affairs, and operations, to ensure cohesive compliance efforts.
- Develop and maintain comprehensive records of compliance activities, audit findings, and corrective actions.
- Serve as the primary point of contact for FDA and other regulatory bodies during audits and inspections.
Key Requirements:
- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
- Proven experience in compliance management within the pharmaceutical industry.
- In-depth knowledge of GMP, FDA, EMA, ICH, and other relevant pharmaceutical industry standards and guidelines.
- Extensive experience with FDA audit preparation and readiness.
- Excellent analytical and problem-solving skills, with the ability to conduct thorough gap analyses and develop effective action plans.
- Strong communication and interpersonal skills, with the ability to train and support client personnel.
- Detail-oriented with strong organizational skills and the ability to manage multiple priorities.
- Proficiency in using compliance management software and tools.
- Willingness to travel to client sites within the Basel region as needed.
Why Join Us?
- Opportunity to work on high-impact compliance projects with a leading pharmaceutical client.
- Collaborate with a team of experts dedicated to advancing compliance, technology, and engineering.
- Be part of a forward-thinking company that values your professional growth and development.
- Enjoy a dynamic and supportive work environment in the Basel region.
Amtera is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
