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Head of Quality

Kelly Services -
Raleigh, NC

Quick Apply

Job Details

Full-time
$195,000 - $215,000 a year

Benefits

Paid holidays
Disability insurance
Relocation assistance
Health insurance
Dental insurance
Vision insurance
Retirement plan
Paid sick time

Qualifications

Coaching
Drug regulation
GMP
Manufacturing facility experience
Team development
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
Regulatory/legal compliance standards in production
Quality control experience within pharmaceutical industry
Manufacturing
Cross-functional collaboration
Cross-functional team management
Stakeholder relationship building
Cross-functional communication
FDA regulations
Senior leadership
Pharmaceutical manufacturing facility experience

Full Job Description

Site Head of Quality

Location: Raleigh, North Carolina
Compensation: $195,000 – $215,000 base salary + 15% annual bonus opportunity
Relocation Assistance: Provided

Reports To: Director, Quality Technical Operations (Solid Line)
Dotted Line: Site Director

Position Summary

We are seeking an experienced and strategic Site Head of Quality to lead all Quality Assurance and Quality Control operations for our commercial sterile manufacturing facility in Raleigh, North Carolina.

This executive-level leader will be responsible for ensuring full compliance with current Good Manufacturing Practices (cGMP), global quality standards, and applicable regulatory requirements while fostering a strong culture of quality throughout the organization. The Site Head of Quality will provide leadership for Quality Operations supporting the manufacturing, testing, packaging, and warehousing of sterile commercial pharmaceutical products and serve as the primary quality representative for regulatory inspections and corporate quality initiatives.

The successful candidate will be a collaborative leader with deep expertise in sterile pharmaceutical manufacturing, regulatory compliance, and quality systems who can influence cross-functional teams and drive continuous improvement across the site.

Key Responsibilities

Champion and cultivate a proactive quality culture aligned with cGMP requirements and global quality standards.
Provide strategic leadership for all Quality Assurance and Quality Control functions, including Quality Systems, Quality Operations, and Microbiology.
Ensure quality systems remain compliant, effective, and continuously improved.
Build, develop, coach, and mentor high-performing quality teams while ensuring appropriate staffing and training.
Establish and monitor key quality performance indicators, communicating results to site leadership and Corporate Quality while driving corrective and preventive actions.
Partner with the Site Leadership Team to execute the site's operational vision and business objectives.
Serve as the primary liaison between the Raleigh site and Corporate Quality, participating in cross-site quality forums and global quality leadership initiatives.
Lead site readiness for regulatory inspections, customer audits, and internal audits.
Act as the primary contact during regulatory inspections and oversee all agency communications and follow-up activities.
Identify, assess, and escalate critical quality issues to Corporate Quality while ensuring timely resolution.
Ensure all quality documentation complies with applicable regulatory requirements and company policies.
Drive corporate quality improvement initiatives by sharing best practices across manufacturing sites.
Establish measurable quality goals aligned with business objectives.
Ensure performance management processes are effectively implemented across the Quality organization.
Perform additional responsibilities as assigned.

Qualifications

Required

Bachelor's degree in Biology, Chemistry, Microbiology, Engineering, or a related scientific discipline; Master's degree preferred.
12–15 years of progressive leadership experience within pharmaceutical manufacturing, including sterile products.
Minimum of 7 years of leadership experience in Quality Assurance and/or Quality Control, ideally with responsibility for both functions.
Extensive knowledge of global pharmaceutical regulations, including FDA, EMA, ANVISA, and MFDS requirements.
Expert knowledge of cGMP regulations and pharmaceutical quality systems.
Demonstrated success leading FDA inspections and regulatory interactions.
Proven experience developing and improving quality systems within a commercial manufacturing environment.
Exceptional leadership, coaching, and organizational development skills.
Strong analytical and problem-solving capabilities with the ability to make sound, data-driven decisions.
Excellent written, verbal, and interpersonal communication skills.
Ability to influence cross-functional teams and build collaborative relationships across the organization.

Preferred

Master's degree in a scientific or engineering discipline.
Experience supporting Finance, Supply Chain, Operational Excellence, or Health, Safety & Environment (HSE) initiatives.
3–5 years of direct experience in sterile pharmaceutical manufacturing operations.

Leadership Competencies

The successful candidate will demonstrate:

Strategic leadership and executive presence
Strong coaching and mentoring abilities
Continuous improvement mindset
Excellent change management skills
Outstanding problem-solving and decision-making capabilities
Effective communication and stakeholder management
Ability to build high-performing, accountable teams
Commitment to integrity, compliance, and quality excellence

Physical & Working Conditions

Ability to lift up to 35 pounds without assistance.
Occasional work in manufacturing environments requiring personal protective equipment (PPE).
Combination of office and manufacturing floor responsibilities.
Frequent computer use.
Domestic and international travel as business needs require.

Organizational Scope

Reports directly to the Director, Quality Technical Operations with a dotted-line relationship to the Site Director.
Leads a team of approximately 5–7 direct reports across Quality Assurance and Quality Control.
Responsible for quality oversight of the Raleigh manufacturing site while collaborating closely with global manufacturing sites and corporate quality organizations.
Responsible for developing and managing the annual Quality department budget.

Compensation & Benefits

Base Salary: $195,000 – $215,000
Annual Bonus: 15% target incentive opportunity
Relocation assistance provided
Comprehensive benefits package
Opportunity to lead quality strategy at a growing sterile pharmaceutical manufacturing site while partnering with global quality leadership.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. 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.

Quick Apply

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