Complaints

Thermo Fisher Scientific•Greenville, NC

6d•Hybrid

About The Position

As part of Thermo Fisher Scientific’s Quality Systems & Compliance leadership team, the Manager, Quality Systems & Compliance – Deviation/CAPA/Complaints oversees quality programs supporting regulatory compliance, investigations, corrective and preventive actions, and customer complaint management across pharmaceutical and medical device operations at the Greenville site. The role leads a team of approximately 3–4 direct reports and collaborates with Quality, Manufacturing, Operations, and other partners to resolve complex quality issues, strengthen quality systems, maintain inspection readiness, and drive continuous improvement. The position provides exposure to multiple client products and portfolios, including expanding medical device operations. The role provides oversight of deviation, CAPA, and complaints programs; investigations and root-cause analysis; CAPA implementation and effectiveness checks; quality metrics and governance reviews; quality documentation and electronic quality management system records; and support for training and process improvements. The manager also supports audits and regulatory inspections, communicates significant quality concerns to leadership, and coaches and develops team members. The position is based in Greenville, North Carolina, with a standard Monday–Friday schedule and hybrid flexibility to work from home one day per week. Travel is approximately 0–10%.

Requirements

Bachelor’s degree in a scientific, engineering, health-related, or closely related technical field.
At least 7 years of experience in the pharmaceutical or medical device industry, including investigations, deviation management, CAPA, Quality Assurance, or related quality systems responsibilities.
At least 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 in 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.
Strong analytical, investigation, and problem-solving skills, including 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.
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 and attention to detail, with demonstrated ability to develop high-performing teams.
Ability to work in an office and manufacturing environment, stand or walk for extended periods as needed, and occasionally lift up to 25 lbs.

Nice To Haves

Experience supporting pharmaceutical manufacturing and medical device quality systems.

Responsibilities

Lead and oversee Deviation, CAPA, and Complaints programs, ensuring compliance with cGMP, 21 CFR Part 211, ICH Q9, ICH Q10, and applicable quality system requirements.
Lead, coach, and develop a team of quality professionals, providing performance guidance and support for professional growth.
Oversee deviation investigations, root-cause analysis, CAPA development and implementation, and effectiveness checks to support timely, 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 in deviation and CAPA management.
Maintain quality documentation, procedures, and electronic quality management system records, and support training and process improvements.
Establish priorities, manage competing business needs, and support quality systems across pharmaceutical and medical device products.