Senior Regulatory Compliance Specialist

3 weeks ago


Reynoldsburg, Ohio, United States Adecco Full time
Job Title: Senior Regulatory and Compliance Specialist

Adecco is seeking a skilled Senior Regulatory and Compliance Specialist to support global regulatory compliance within the pharmaceutical industry. The ideal candidate will be experienced in pharmaceutical regulations, compliance practices, and their impact on manufacturing. This role offers high visibility, working across various functional areas including Supplier Quality, Regulatory Compliance, DEA, and QMS.

Key Responsibilities:

  • Manage the Supplier Quality program, ensuring compliance deliverables are met.
  • Facilitate customer audits to ensure cGMP, Corporate, and site SOP compliance.
  • Lead internal audits, ensuring adherence to FDA and international health authority regulations.
  • Prepare the site for US FDA and international regulatory inspections, participating in all aspects from initiation through closure.
  • Assist in responding to audit observations, ensuring timely and comprehensive follow-up.
  • Lead the internal audit program and escalate unresolved audit findings.
  • Participate in the preparation of PAI audits for new product approvals.
  • Contribute to Supplier and Customer Quality Agreements and represent the site in global regulatory meetings.
  • Approve TrackWise records and maintain departmental SOPs.

Qualifications:

  • Bachelor's degree with 5+ years of experience in Quality/Regulatory Compliance or associated pharmaceutical manufacturing roles, OR
  • Associate degree or High School Diploma with 10+ years of related experience.
  • In-depth knowledge of FDA regulatory requirements and cGMP regulations for solid oral dosage forms.
  • Experience with TrackWise and ASQ CQA certification is preferred.

About Adecco:

Adecco is a global leader in HR services, connecting over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world. We offer employment opportunities at any stage in your professional career. Contact us today to discuss available contract and direct hire positions.

Benefits:

Adecco provides one of the most comprehensive benefits packages in the industry, including medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs.

Equal Opportunity Employer/Veterans/Disabled:

Adecco will consider qualified applicants with arrest and conviction records for employment.



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