Manager, Quality Systems & Compliance - Deviation/CAPA/Complaints

Regulatory Toolkit; Greenville (NC); Ibrido; USD 120.000 - 170.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, Dental, Vision benefits

401K company match

Tuition reimbursement – eligible after

Employee referral bonus

Employee discount program

Recognition program

Charitable gift matching

Company paid parental leave

Career advancement opportunities

Descrizione del lavoro

Thermo Fisher Scientific is seeking a Manager, Quality Systems & Compliance – Deviation/CAPA/Complaints in Greenville, NC. You will lead critical quality programs to support regulatory compliance, investigations, CAPA, and customer complaints across our expanding operations.

You will manage a team of quality professionals, collaborate with cross-functional partners, and drive continuous improvement while maintaining inspection readiness.

Competenze

• Bachelor's degree in a scientific, engineering, health-related, or closely related technical field.
• Experience in pharmaceutical or medical device quality systems.
• Strong knowledge of FDA regulations and cGMP requirements.

Mansioni

• Lead Deviation/ CAPA/ Complaints programs and ensure compliance.
• Oversee quality investigations and root-cause analysis.
• Coordinate cross-functional quality improvements and risk-based decisions.
• Support internal and regulatory audits and inspections.
• Coach and develop a high-performing quality team.

Conoscenze

Quality Systems

Regulatory compliance

Investigations

CAPA

Leadership

Cross-functional

Quality metrics

Inspection readiness

Formazione

Bachelor's degree in scientific/engineering/health-related field

Strumenti

TrackWise

Veeva Vault

MasterControl

Descrizione del lavoro

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Manager, Quality Systems & Compliance – Deviation/CAPA/Complaints

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.

Excellent Benefits Package

Review our company’s Total Rewards

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 5%

Tuition Reimbursement – eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

Location/Division Specific Information

Greenville, NC

Schedule: Monday–Friday, standard business hours | Hybrid flexibility: Work from home one day per week

Travel: Approximately 0–10%

Discover Impactful Work:

Join our Quality Systems & Compliance leadership team and help shape the future of quality across our growing pharmaceutical and medical device operations.

As a Manager, Quality Systems & Compliance – Deviation/CAPA/Complaints, you will oversee critical quality programs that support regulatory compliance, effective investigations, corrective and preventive actions, and customer complaint management across our expanding business.

This is an opportunity to lead a focused team of quality professionals while collaborating across functions to solve complex challenges, strengthen quality systems, and drive continuous improvement. With continued growth in our medical device portfolio and pharmaceutical manufacturing operations, you'll have the opportunity to expand your leadership capabilities while making a meaningful impact on quality performance and operational excellence.

A Day in the Life:

You will lead a team of approximately 3–4 direct reports responsible for supporting deviation, Corrective and Preventive Action (CAPA), and complaints management programs across the Greenville site.

Your responsibilities will include providing oversight of quality investigations, monitoring program performance, ensuring timely CAPA execution, and identifying opportunities to improve quality processes. You'll work closely with Quality, Manufacturing, Operations, and other cross-functional partners to resolve complex quality issues, maintain inspection readiness, and support effective risk-based decision‑making.

As a people leader, you'll coach and develop your team, establish priorities, and foster a collaborative, accountable environment. This role offers broad exposure to multiple client products and portfolios, including expanding medical device operations.

What to expect:

• Provide leadership and oversight of the Deviation, CAPA, and Complaints programs, ensuring compliance with cGMP, 21 CFR Part 211, ICH Q9, ICH Q10, and applicable quality system requirements.
• Lead and develop a team of quality professionals, providing coaching, performance guidance, and support for professional growth.
• Oversee deviation investigations, root cause analysis, CAPA development, implementation, and effectiveness checks to ensure timely and sustainable resolution of quality issues.
• Monitor quality metrics, identify recurring trends, facilitate governance reviews, and communicate program performance and significant quality concerns to leadership.
• Collaborate with cross‑functional stakeholders to resolve quality challenges, improve investigation effectiveness, and drive continuous improvement initiatives.
• Support internal and external audits, client inspections, and regulatory inspections as a subject matter expert for deviation and CAPA management.
• Maintain effective quality documentation, procedures, and electronic quality management system records while supporting training and process improvements.
• Establish priorities, manage competing business needs, and support quality systems across pharmaceutical and medical device products.

Keys to Success:

Education

Bachelor's degree in a scientific, engineering, health‑related, or closely related technical field.

Experience

• Minimum of 7 years of experience in the pharmaceutical or medical device industry, including investigations, deviation management, CAPA, Quality Assurance, or related quality systems responsibilities.
• Minimum of 5 years of leadership experience with direct reports, including employee development, coaching, and performance management.
• Demonstrated experience overseeing deviation investigations, CAPA implementation, effectiveness checks, and complaints management within a regulated environment.
• Strong understanding of FDA regulatory requirements, cGMP, 21 CFR Part 211, ICH Q9, ICH Q10, and pharmaceutical quality systems.
• Experience using electronic quality management systems such as TrackWise, Veeva Vault, MasterControl, or similar platforms.
• Excellent analytical, investigation, and problem‑solving skills with the ability to identify root causes and implement effective corrective actions.
• Strong communication, interpersonal, and stakeholder management skills with the ability to influence and collaborate across organizational levels.
• Proven ability to lead cross‑functional initiatives, manage competing priorities, and deliver results within established timelines.
• Experience with quality metrics, trend analysis, risk management, inspection readiness, and continuous improvement.
• Strong organizational skills, attention to detail, and demonstrated ability to develop high‑performing teams.
• Experience supporting pharmaceutical manufacturing and medical device quality systems is highly desirable.
• Physical requirements include the ability to work in an office and manufacturing environment, stand or walk for extended periods as needed, and occasionally lift up to 25 lbs.