Senior Manager Regulatory Compliance

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

The Quality Assurance Compliance Manager is responsible for ensuring that the organization's products and services meet all quality standards and regulatory requirements. This role involves developing and implementing quality assurance policies, conducting audits, and training employees on quality standards. This includes, but is not limited to, ensuring site compliance with FDA, EMA and other cGMP regulations, overseeing programs including compliance, risk management and metrics. This individual provides leadership to assigned staff by performing the following: developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.

What will you do?

• Quality Assurance Program Development:
  • Develop, implement, and maintain quality assurance policies and procedures.
  • Ensure that quality assurance programs comply with regulatory requirements and industry standards.
• Quality Audits and Inspections:
  • Conduct regular internal audits and inspections to ensure compliance with quality standards.
  • Identify areas for improvement and recommend corrective actions.
• Regulatory Compliance:
  • Stay updated with regulatory changes and ensure that quality assurance practices meet all regulatory requirements.
  • Prepare for and manage external audits and inspections by regulatory bodies.
• Training and Education:
  • Develop and deliver training programs on quality assurance and compliance standards.
  • Ensure that all employees are knowledgeable about quality requirements relevant to their roles.
• Documentation and Reporting:
  • Maintain accurate and comprehensive documentation of quality assurance activities.
  • Prepare and present reports on quality assurance and compliance issues to senior management.
• Continuous Improvement:
  • Identify opportunities for continuous improvement in quality assurance processes.
  • Implement best practices to enhance product and service quality.
• Risk Management:
  • Identify quality risks and develop strategies to mitigate these risks.
  • Investigate quality issues and work with relevant departments to resolve them.
• Stakeholder Collaboration:
  • Collaborate with various departments to ensure a cohesive approach to quality assurance.
  • Provide guidance and support to departments on quality and compliance matters.
• Reviews and approves department standard operating procedures.
• Oversees daily activity for the group to ensure appropriate quality, to ensure commitments are met and maintenance of schedules.
• Provide support for site safety initiatives.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities.
• As part of the role, you will represent the company at regulatory inspections, respond to questions, support responses and corrective actions as appropriate.
• Oversees daily activity for the group to ensure appropriate quality and output and maintenance of schedules. May assist in performing tasks of the group.
• Sets objectives and tasks for staff and regularly review staff progress in meeting objectives.
• Effectively communicates with peers, Manufacturing, Process Development, Procurement and Quality Control staff, to resolve technical issues and direct activities.
• Provides support to site safety initiatives.

REQUIREMENTS:
• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in compliance management within a multinational company
• Preferred Fields of Study: Transportation, Logistics, Business, International Trade, Science, Engineering, or Pharmacy
• Professional auditor certifications (e.g., IRCA, ASQ) preferred
• Customs Broker License a plus
• Expertise in global import/export regulations, customs procedures, and trade compliance
• Strong knowledge of U.S. and international trade laws, including export controls and customs regulations
• Advanced proficiency in compliance management systems (e.g., OneSource, ACE)
• Experience with ERP systems (SAP, E1, QAD) and data analytics tools
• Demonstrated ability to develop and implement compliance policies and procedures
• Strong project management and process improvement capabilities
• Strong stakeholder management and cross-cultural communication
• Experience managing and developing teams
• Strong analytical and problem-solving skills
• Ability to work independently and handle multiple priorities
• Strong presentation and written communication skills
• Proficiency in English; additional language skills valued for international roles
• Ability to travel up to 20-25% as required
• Commitment to Thermo Fisher Scientific values: Integrity, Intensity, Innovation, and Involvement