Regulatory Compliance Expert
5 days ago
Adecco US, Inc. is seeking a highly skilled Regulatory Compliance Expert to join their team in a pharmaceutical industry role. This position offers competitive compensation and the potential for full-time employment.
As a Regulatory Compliance Expert, you will play a critical role in ensuring compliance with global regulations within the pharmaceutical industry. Your responsibilities will include managing the supplier quality program, conducting audits, and leading inspection preparation activities.
Key Responsibilities:
- Manage supplier quality program and ensure compliance with Supplier Quality Management deliverables.
- Conduct and host customer and internal audits to ensure compliance with cGMPs, corporate, and site standard operating procedures.
- Lead inspection preparation activities for US FDA and foreign regulatory authorities.
- Lead the internal audit program at the site.
- Prepare and submit written responses to audit findings and regulatory observations.
- Initiate deviations when necessary and participate in PAI audits.
- Participate in supplier and customer quality agreements, as well as global meetings.
- Review and approve TrackWise records and revise departmental SOPs as needed.
- Adhere to environmental, health, and safety requirements.
Requirements:
- Bachelor's degree with 5+ years of experience in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems, or related manufacturing function.
- Deep understanding of FDA and cGMP regulations pertaining to clinical and commercial pharmaceutical drug manufacturing activities.
- Knowledge of US FDA regulatory requirements for solid oral dosage forms preferred.
- Experience with audit types and techniques.
- TrackWise experience preferred.
- ASQ CQA or relevant certification highly preferred.
Benefits:
- Competitive compensation.
- Opportunity for full-time employment.
- Medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, and a 401K plan.
- Equal Opportunity Employer/Veterans/Disabled.
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