Regulatory Compliance- Operations Manufacturing

By | January 28, 2026

Regulatory Compliance- Operations Manufacturing

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Job ID: 10049106

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Philadelphia, PA, US

Scientific

Bachelors Degree

Full Time, Direct Hire

$100,000+

Experienced (Non-Manager)

On-site

Biotechnology/Pharmaceuticals

First Shift (Day)

Philadelphia, PA, US

$100,000+

Experienced (Non-Manager)

Full Time, Direct Hire

Biotechnology/Pharmaceuticals

On-site

Scientific

Bachelors Degree

First Shift (Day)

Apply Now Applied

Job details

Regulatory Compliance- Operations & Manufacturing

Regulatory & Quality Compliance

  • Lead remediation of regulatory compliance issues related to enterprise standards, local procedures, and global regulations (FDA, EU MDR, ISO, MHRA, DSCSA, State Board of Pharmacy).


  • Serve as a Subject Matter Expert (SME) on regulatory compliance requirements supporting operations and manufacturing.

Audit & Inspection Readiness

  • Drive inspection readiness activities, including training, audit logistics, request management, and daily audit communications.


  • Lead Internal Audit (IA) and External Audit (EA) programs, including planning, execution, reporting, and follow-up.


  • Develop and maintain audit policies, procedures, schedules, playbooks, templates, and metrics.


  • Serve as backroom lead and primary point of contact during regulatory inspections and Notified Body audits (announced and unannounced).


  • Remediate audit findings and lead CAPA investigations and execution.

Program & Process Development

  • Design and implement vendor license verification processes and manage third-party compliance tools and databases.


  • Establish and manage State Board of Pharmacy licensing programs, including applications, renewals, monitoring, and record retention.


  • Develop and implement governance frameworks, policies, procedures, and work instructions to support regulatory compliance.


  • Create practical system and process solutions to address complex regulatory and operational challenges.

Cross-Functional Leadership & Training

  • Collaborate with global and regional stakeholders to support strategic initiatives and technology-driven compliance enhancements.


  • Lead and facilitate global training programs on regulatory compliance topics, including EU MDR, CAPA, inspection readiness, data integrity, and combination products.

Required

  • Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field (or equivalent experience).


  • 7+ years of experience in Regulatory Compliance and Audit Management within medical device, pharmaceutical, or regulated healthcare industries.


  • In-depth knowledge of FDA regulations, EU MDR, ISO standards, MHRA requirements, and audit processes.


  • Proven experience leading internal and external audits, inspections, and global compliance initiatives.

Preferred

  • Lead Auditor certification or equivalent training.


  • Experience managing DSCSA compliance and State Board of Pharmacy licensing.


  • Experience supporting global organizations and cross-regional stakeholders.


  • Strong project management, communication, and stakeholder-influencing skills.

Key Competencies

  • Regulatory compliance expertise and audit leadership


  • Inspection readiness and CAPA management


  • Auditing manufacturing environment where operations are occurring

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