Sr Compliance Specialist

Thermo Fisher Scientific • Ridgefield, NJ

7d

About The Position

As part of Thermo Fisher Scientific, the Sr Compliance Specialist supports quality systems for investigational new drugs, biologics, and/or medical devices. The role helps ensure systems meet current industry, regulatory, and customer requirements and that operations remain in a state of control. The specialist also assists the QA Director in maintaining established systems.

The position maintains quality processes for Change Control, Deviations, Out of Specification results, Corrective and Preventative Actions, Complaints, investigation reports, and follow-up actions. It establishes and maintains Standard Operating Procedures (SOPs), including periodic reviews to ensure alignment with regulatory and global requirements, and provides training to support employee understanding and retention.

The specialist audits departments, prepares audit reports, identifies trends, and assesses quality-system performance. The role provides oversight of vendor qualifications and supplier-management matters, helps maintain facility compliance and audit readiness, and delivers compliance and corrective-action training. It also trains new employees and junior team members on Thermo Fisher procedures and cGMP regulations.

Working independently as a Quality Assurance Representative, the specialist maintains knowledge of ICH requirements, ensures APQRs are generated, reviewed, and submitted, and partners with site and network resources on supplier quality issues. The role participates in cross-functional process-control, improvement, optimization, and other continuous-improvement projects, and performs other assignments as required.

Requirements

• Advanced degree plus 2 years of experience, or a bachelor's degree in Chemistry, Biology, or a related scientific discipline plus 5 years of experience.
• Excellent project-management and problem-solving abilities.
• Strong written and verbal communication skills in English.
• Ability to work independently and collaborate effectively in a matrix environment.
• Proven track record of building relationships with suppliers and interdepartmental groups.

Responsibilities

• Maintain Change Control, Deviation, Out of Specification, Corrective and Preventative Action, Complaint, and investigation-report systems, including follow-up actions.
• Establish and routinely maintain SOPs, including periodic reviews to ensure alignment with regulatory and global requirements.
• Provide training as needed to support retention of procedures and requirements.
• Audit departments for compliance with quality systems, generate audit reports, identify trends, and assess quality-system performance.
• Provide quality oversight of vendor qualifications, including questionnaires, quality agreements, and vendor audit schedules.
• Help maintain facility compliance status and audit readiness.
• Implement quality-compliance and corrective-action training.
• Train new employees and junior team members on Thermo Fisher procedures and cGMP regulations.
• Work independently on projects as a Quality Assurance Representative.
• Maintain current knowledge of ICH requirements to ensure quality-system compliance.
• Ensure APQRs are generated, reviewed, and submitted.
• Partner with site Logistics and Quality Assurance teams and network resources to oversee supplier management and site-specific supplier quality issues.
• Participate in cross-functional process-control, improvement, and optimization projects, and other continuous-improvement projects to enhance client satisfaction.
• Complete other assignments and tasks as required.

Benefits

• Choice of national medical and dental plans and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off (PTO) and 10 paid holidays annually.
• Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
• Accident and life insurance, and short- and long-term disability in accordance with company policy.
• 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount.
• Potential eligibility for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior