Lead Compliance- Operations Manufacturing

General Information

Name

Lead Compliance
- Operations Manufacturing

Employment Type

Direct Hire

Position level

Full-time

Virtual/Remote?

No

Labor Category

Scientific

Date

10-Feb-2026

City

Philadelphia

State

Pennsylvania

Country

United States

#

Description & Requirements

Description

Lead Compliance & cGMP Operations
- Philadelphia, PA
100% Onsite
- Permanent Position
Position Summary
Compliance Lead & cGMP Operations provides strategic leadership and subject matter expertise in the development, implementation, and oversight of compliance programs supporting cGMP operations. This role ensures sustained regulatory compliance across internal operations and third-party partners while driving continuous improvement, inspection readiness, and organizational quality culture in support of 503B outsourcing facility requirements.
Key Responsibilities

• Lead the design, implementation, and continuous enhancement of company-wide compliance programs focused on cGMP operations.
• Provide strategic oversight of routine and for-cause compliance assessments and audits of internal departments and third-party providers, including suppliers, manufacturers, and contract laboratories.
• Interpret evolving regulatory requirements and proactively assess business impact, identifying compliance risks and partnering with internal stakeholders to support informed strategic planning and decision-making.
• Serve as the primary point of contact for monitoring and communicating regulatory and guidance updates affecting 503B outsourcing facility operations, ensuring timely company-wide notification and implementation.
• Lead and coordinate regulatory interactions, including responses, information transfers, and communications with regulatory agencies.
• Support and lead regulatory inspections by responding to inquiries, facilitating inspections, and ensuring timely, accurate, and compliant reporting.
• Oversee the development, implementation, and effectiveness of compliance training programs to ensure employees maintain a thorough understanding of applicable regulatory requirements.
• Ensure robust documentation practices are maintained for manufacturing processes and quality systems to demonstrate sustained compliance.
• Drive root cause analysis and the implementation of corrective and preventive actions (CAPAs) in response to compliance issues, audit findings, and identified improvement opportunities.
• Establish and maintain effective working relationships with internal stakeholders, external partners, and regulatory authorities to promote transparency, alignment, and compliance excellence.
• Partner closely with Quality Assurance and cross-functional teams to strengthen and continuously improve the Quality Management System (QMS).
• Ensure compliance with GxP, FDA, ICH, OSHA, and 21 CFR Part 11 requirements across all applicable operations.

Qualifications

• Must have a Bachelor's degree in Chemistry, Biology, or Pharmacy.
• Extensive knowledge of cGMP regulations and compliance requirements applicable to pharmaceutical manufacturing and 503B outsourcing facilities.
• Strong familiarity with GxP, FDA, ICH, OSHA regulations, and 21 CFR Part 11.
• Demonstrated experience leading audits, inspections, CAPA programs, and regulatory interactions.
• Excellent communication, organizational, and decision-making skills.

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.  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…