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 youll 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 worlds 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 organizations 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 Bachelors 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

Required Experience:

Senior Manager