Quality Compliance Manager

RXinsider LTD.; Middletown (VA); On-site; USD 94,000 - 141,000; Full time

Benefits offered by this job

Medical plans

Dental plan

Vision plan

401(k) plan

ESPP

PTO 120 hours

Parental leave

Job summary

Thermo Fisher Scientific in Middletown, VA is seeking a Quality Compliance Manager to lead regulatory compliance, audits, and CAPA activities. You will partner with Quality, Operations, and Regulatory Affairs to strengthen processes and maintain sustained compliance.

You will manage a team of compliance professionals, drive continuous improvement, and ensure readiness for regulatory inspections across the site.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Quality, or related discipline.
• 4+ years in Quality, Compliance, Regulatory Affairs, or related function in regulated environments.
• Experience supporting internal, customer, and third-party audits and regulatory inspections.
• Experience coordinating CAPA activities and maintaining audit readiness.
• Lead cross-functional projects and teams with strong communication.

Responsibilities

• Lead site compliance programs to maintain regulatory requirements and customer expectations.
• Plan, coordinate, and manage internal, customer, and regulatory audits and inspections.
• Provide guidance during inspections and coordinate responses to observations.
• Develop and monitor CAPA activities and remediation efforts.
• Grow a culture of quality, accountability, and continuous improvement.

Skills

GMP knowledge

FDA regulations

Audit management

CAPA leadership

Regulatory affairs

Quality systems

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences

Engineering qualification

Quality discipline

Tools

TrackWise

MasterControl

Job description

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

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 and 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 take science a step beyond by developing solutions for some of the world’s toughest challenges.

Discover Impactful Work

Join the Clinical Diagnostics Division as a Quality Compliance Manager and play a critical leadership role in maintaining regulatory compliance, audit and inspection readiness, and the effectiveness of our quality systems.

In this role, you will lead compliance activities across the site, including internal and external audits, regulatory and customer inspections, responses to observations and findings, and corrective and preventive action (CAPA) activities. You will partner closely with Quality, Operations, Regulatory Affairs, and other cross-functional teams to identify compliance risks, strengthen processes, and maintain sustained compliance with applicable regulatory standards and customer requirements.

As a people manager, you will also lead and develop a team of compliance professionals, establish priorities, provide coaching and technical guidance, and foster a culture of accountability, quality, and continuous improvement.

Location

This position is based in Middletown, VA.

Key Responsibilities

• Lead, coach, and develop direct reports, establishing clear priorities, performance expectations, and development objectives.
• Provide technical and compliance guidance to team members and support their continued professional development.
• Lead site compliance programs designed to maintain adherence to applicable regulatory requirements, quality standards, internal procedures, and customer expectations.
• Maintain a state of ongoing audit and inspection readiness across relevant functions and quality systems.
• Plan, coordinate, and manage internal audits, customer audits, third party audits, and regulatory inspections.
• Serve as a key site compliance representative during regulatory inspections and customer audits, coordinating activities across internal stakeholders.
• Lead and coordinate timely, accurate, and comprehensive responses to regulatory observations, audit findings, and customer observations.
• Oversee the development, implementation, and effectiveness of corrective and preventive actions (CAPAs) associated with compliance observations and findings.
• Monitor CAPA commitments and other remediation activities to support timely and sustainable resolution.
• Identify, assess, communicate, and elevate compliance risks and emerging trends to appropriate stakeholders and leadership.
• Interpret applicable regulatory requirements and translate them into practical quality and compliance processes.
• Partner with Quality, Operations, Regulatory Affairs, and other cross functional teams to strengthen compliance and quality systems.
• Lead cross functional compliance initiatives and continuous improvement activities.
• Establish, monitor, and analyze compliance metrics and key performance indicators to identify trends, risks, and opportunities for improvement.
• Support the development and maintenance of compliance procedures, policies, and supporting documentation.
• Promote a strong culture of quality, integrity, accountability, and compliance throughout the organization.

Education

• Bachelor’s degree in Life Sciences, Engineering, Quality, or a related discipline.

Experience

• 4+ years of experience in Quality, Compliance, Regulatory Affairs, or a related function within a regulated pharmaceutical, biotechnology, medical device, diagnostics, or life sciences environment preferred.
• Demonstrated experience supporting or managing internal audits, customer audits, third party audits, and regulatory inspections.
• Experience coordinating responses to regulatory observations and audit findings and managing associated CAPA activities.
• Experience maintaining audit and inspection readiness within a regulated environment.
• Experience leading cross functional projects or compliance initiatives.
• People leadership, supervisory, or team leadership experience preferred.

Knowledge, Skills And Abilities

• Strong knowledge of applicable FDA regulations, Good Manufacturing Practices (GMP), ISO 13485, and other relevant quality and regulatory requirements.
• Ability to interpret regulatory and quality requirements and translate them into effective, sustainable compliance practices.
• Strong understanding of audit, inspection, CAPA, risk management, and quality-system principles.
• Ability to lead, coach, develop, and engage team members while establishing clear expectations and accountability.
• Strong project management skills with the ability to coordinate multiple priorities and cross functional initiatives.
• Ability to analyze compliance data and metrics, identify trends and risks, and develop appropriate improvement actions.
• Experience with electronic quality management systems and compliance tools; experience with platforms such as TrackWise or MasterControl is preferred.
• Excellent written and verbal communication, presentation, and stakeholder management skills.
• Ability to communicate and influence effectively across functions and organizational levels.
• Strong analytical, organizational, and problem solving skills with attention to detail.
• Ability to exercise sound judgment, appropriately elevate compliance concerns, and operate effectively in a regulated environment.

Compensation And Benefits

The salary range estimated for this position based in Virginia is $93,800.00–$140,675.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A 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 paid time off (PTO), 10 paid holidays annually, paid parental leave (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
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards