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External Supply Operations Quality (ESOQ) Manager
Job Description
Job description:
We are seeking an External Supply Operations Quality (ESOQ) Manager to oversee quality and regulatory activities for global contract manufacturing organizations (CMOs). This role plays a critical part in ensuring products meet cGMP standards, regulatory requirements, and internal quality expectations.
You will serve as a key liaison between external partners and internal teams, leading cross-functional collaboration and driving a compliant, risk-based quality culture.
Key Responsibilities:
- Manage quality (80%) and regulatory (20%) oversight for assigned CMOs
- Ensure compliance with cGMPs, regulatory filings, and country-specific requirements
- Act as primary quality contact for contractors and lead cross-functional teams
- Support regulatory submissions, change controls, and post-approval activities
- Participate in audits, site visits, and virtual quality teams
- Perform lot disposition for biotech products (as applicable)
Qualifications:
- Bachelor’s degree in Science, Engineering, or related field
- 7+ years in GxP and/or Regulatory Affairs
- 4+ years in GMP Quality Assurance (aseptic manufacturing required)
- Experience with CMOs and complex quality/compliance environments
- Familiarity with systems such as SAP, PDM, or similar platforms
- Strong communication, negotiation, and project management skills
- Ability to work independently in a global environment
- Willingness to travel up to 20%
#QualityAssurance #Pharmaceuticals #GMP #RegulatoryAffairs #Biotech #SupplyChain #LifeSciences #QualityManagement #PharmaJobs #Operations
#LI-AF1
Additional Information
HKA Enterprises is a global workforce solutions firm. If you're seeking a new career opportunity or project experience, our recruiters will work to understand your qualifications, experience, and personal goals. At HKA, we recognize the importance of matching employee goals with those of the employer. We strive to seek credibility, satisfaction, and endorsement from all of our applicants. We invite you to take time and search for your next career experience with us! HKA is an EEO Employer who participates in the US Citizenship and Immigration Services E-Verify Program.
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