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Job Title:** **Manager, Compliance & Support – Drug Product

**Location:** Onsite – Holly Springs, NC

**Job Type:** Full-Time

**Estimated Salary Range:** $110,000 – $135,000 per year (depending on experience and qualifications)

Overview:

We are seeking a skilled and motivated **Manager, Compliance & Support** to lead the Drug Product Manufacturing Support team. This role is responsible for ensuring GMP compliance, overseeing batch documentation, supporting regulatory inspections, and driving operational excellence across drug product operations. The ideal candidate will have a strong background in GMP manufacturing environments, proven leadership experience, and expertise in supporting compliance systems such as batch record review, deviations, and CAPAs.

Key Responsibilities:

+ Lead and manage a cross-functional Manufacturing Support team, including schedulers, MES associates, batch record reviewers, and training coordinators.

+ Develop and implement departmental SOPs and create/maintain master batch records in electronic systems.

+ Provide compliance oversight and support for floor activities, including deviations, investigations, and CAPA management.

+ Act as a lead point of contact for regulatory audits and inspections related to Drug Product manufacturing support.

+ Coordinate non-batch manufacturing activities and change control processes using systems such as TrackWise.

+ Track and manage key performance indicators (KPIs), including batch record review timelines and production cycle time.

+ Support materials management in collaboration with supply chain and operations teams.

+ Develop team members through coaching, performance evaluations, and professional development planning.

+ Participate in recruiting, onboarding, and employee retention strategies.

+ Administer company policies related to scheduling, time off, and other personnel matters.

+ Lead or contribute to continuous improvement initiatives to enhance operational efficiency and compliance.

Basic Requirements:

+ Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, or related field with **7+ years** of direct experience in drug product manufacturing, OR

+ Associate degree with **9+ years** of relevant experience, OR

+ High school diploma or GED with **11+ years** of experience in pharma/biotech operations

+ Minimum **1-2 years** of people management or team leadership experience

+ Experience working in a regulated **GMP environment**

Preferred Qualifications:

+ **2–5 years** of people management experience in a manufacturing support or compliance function

+ Background in **aseptic processing** , sterile manufacturing, or drug product quality assurance

+ Familiarity with **TrackWise** , MES systems, and electronic batch record platforms

+ Completion of Bioworks or BTEC coursework is a plus

Work Environment & Physical Requirements:

+ This is an **onsite position** located in **Holly Springs, NC**

+ Must be able to sit or stand for extended periods

+ Ability to perform tasks involving repetitive motions of hands and wrists

+ May require lifting of materials up to 10 lbs

+ Must be able to visually inspect documentation or products with 20/20 corrected vision

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. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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 Services is proud to be an Equal Employment Opportunity and Affirmative 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.