Director, Quality Compliance (DEA)

Kelly Services; Greenville (SC); On-site; USD 180,000 - 220,000; Full time

Benefits offered by this job

Retirement savings plan

Paid holidays

Transit benefit

Medical benefits

Job summary

Kelly Services seeks a Sr. Director of Quality Compliance (DEA) in Greenville, SC to lead enterprise-wide compliance strategy, governance, audit readiness, and quality risk management.

This onsite leadership role oversees QMS, supplier quality, and inspection readiness, partnering with Manufacturing, Regulatory, and Executive teams to sustain cGMP and DEA compliance. Ideal candidates bring 15+ years in pharmaceutical quality with FDA interactions, and a track record of driving CAPAs and

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical Engineering, or related science.
• 15+ years of progressive pharmaceutical quality experience in GMP environments.
• Senior leadership in Quality/Regulatory Compliance with FDA interactions.

Responsibilities

• Develop and implement enterprise quality compliance strategies and policies.
• Lead inspection readiness and manage regulatory inspections.
• Oversee QMS processes including change control, deviations, CAPAs, and document management.
• Drive quality metrics, CAPAs, and risk management across functions.
• Lead cross-functional Quality Compliance teams and report to senior leadership.

Skills

Leadership

Regulatory Affairs

Quality Systems

Audit Readiness

Cross-functional Collaboration

Strategic Thinking

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, Chemical Engineering, or related science

Job description

Sr. Director of Quality Compliance (DEA)

Full-Time | Senior Leadership

Location: Greenville, SC (Onsite Role)

Compensation: Approximately $180,000-$220,000 base salary + bonus potential

Position Summary

A growing pharmaceutical manufacturing organization is seeking a Sr. Director of Quality Compliance to lead enterprise-wide compliance strategy, governance, audit readiness, inspection management, escalation processes, and quality risk management activities. This individual will serve as a key member of the Quality Leadership team and will drive continuous improvement initiatives to ensure sustained compliance with cGMP, FDA, DEA, DSCSA, and international regulatory requirements.

This role will oversee quality compliance systems and inspection readiness programs while partnering cross-functionally with Quality, Manufacturing, Regulatory, Supply Chain, and Executive Leadership teams. The ideal candidate will bring deep expertise in pharmaceutical quality systems, regulatory inspections, auditing, and enterprise compliance strategy within GMP-regulated manufacturing environments.

Key Responsibilities

Quality Compliance & Regulatory Oversight

• Develop and implement enterprise quality compliance strategies, programs, and policies
• Ensure compliance with FDA, DEA, cGMP, ICH, DSCSA, and global regulatory requirements
• Lead inspection readiness programs and provide on-site support during regulatory inspections
• Serve as the primary escalation point for significant quality and compliance risks
• Manage quality notification-to-management and escalation programs
• Interpret evolving regulatory requirements and implement systemic compliance improvements

Audit & Inspection Management

• Direct internal audit programs across manufacturing and quality operations
• Lead and manage external audits conducted by FDA, DEA, notified bodies, clients, and global health authorities
• Review audit observations and drive effective CAPA implementationMaintain audit-ready quality systems and documentation practices
• Track and trend quality indicators and compliance metrics

Quality Systems & Risk Management

• Oversee core Quality Management System (QMS) processes including:
• Change control
• Deviations
• CAPAs
• Document management
• Supplier quality
• Escalation management
• Analyze quality data and trends to identify systemic risks and improvement opportunities
• Ensure effective statistical monitoring and reporting of quality compliance metrics
• Support post-market surveillance and ongoing product quality monitoring activities

Leadership & Cross-Functional Collaboration

• Lead and develop Quality Compliance teams and associated quality personnel
• Partner with Manufacturing, Quality Control, Regulatory Affairs, and Executive Leadership to drive strategic quality initiatives
• Foster a culture of compliance, accountability, and continuous improvement
• Support implementation of quality-focused operational efficiencies and business improvements
• Present quality compliance updates and risk assessments to senior leadership

Continuous Improvement & Strategy

• Drive initiatives focused on improving inspection outcomes, audit performance and overall quality culture
• Lead implementation of systemic process improvements across manufacturing and quality operations
• Evaluate and enhance quality systems effectiveness through analytics and risk management principles
• Support modernization initiatives involving predictive analytics, technology platforms, and quality data visibility

Qualifications

Required Education & Experience

• Bachelor's degree in Pharmacy, Chemistry, Biology, Chemical Engineering, or related scientific discipline
• 15+ years of progressive pharmaceutical quality experience within GMP-regulated manufacturing environments
• Prior senior leadership experience in Quality Compliance, Quality Assurance, or Regulatory Compliance
• Strong experience interacting directly with FDA and global regulatory agencies

Technical Expertise

• Deep knowledge of:
• cGMP regulations
• FDA and global regulatory requirements
• DEA compliance
• Quality systems and auditing
• Risk management principles
• Pharmaceutical manufacturing operations
• Experience supporting API, aseptic, sterile, or OTC manufacturing environments preferred
• Strong understanding of:
• Deviations
• CAPAs
• Change controls
• Inspection readiness
• Supplier quality management
• Data integrity

Additional Information

• Travel up to approximately 40% may be required
• Relocation assistance may be available
• Experience within pharmaceutical manufacturing, CDMO, or highly regulated GMP environments strongly preferred

Benefits

• Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.
• As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.
• In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Affirmitive Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.