Complaints

Thermo Fisher Scientific•Greenville, NC

7d•Hybrid

About The Position

The Manager, Quality Systems & Compliance – Deviation/CAPA/Complaints leads critical 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 works with Quality, Manufacturing, Operations, and other partners to address complex quality issues, maintain inspection readiness, strengthen quality systems, and drive continuous improvement. The manager oversees deviation, CAPA, and complaints programs; monitors performance and quality metrics; ensures timely and sustainable resolution of quality issues; supports audits and inspections; and maintains effective documentation and electronic quality-system records. The position also coaches and develops team members, sets priorities, and supports quality systems across multiple products and portfolios. The role is based in Greenville, North Carolina, with a Monday–Friday standard business-hours schedule, hybrid flexibility to work from home one day per week, and approximately 0–10% travel. The work environment includes office and manufacturing settings.

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.
Excellent analytical, investigation, and problem-solving skills, including identifying root causes and implementing 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, attention to detail, and 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 is highly desirable.

Responsibilities

Lead and oversee Deviation, CAPA, and Complaints programs to ensure compliance with applicable regulations and quality-system requirements.
Lead, coach, and develop a team of quality professionals, including providing performance guidance and supporting professional growth.
Oversee deviation investigations, root-cause analysis, CAPA development and implementation, and effectiveness checks.
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.