Regulatory Compliance Expert
3 weeks ago
Adecco US, Inc. is seeking a highly skilled Regulatory Compliance Expert to support our client's team in Somerset, NJ.
This role offers competitive compensation ($53.00/hour) with the potential for full-time employment at the end of the 3-month contract period.
As a Regulatory Compliance Expert, you will play a critical role in ensuring compliance with global regulations within the pharmaceutical industry.
You will be responsible for 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 ($53.00/hour)
- Full-time employment potential at the end of the 3-month contract period
- Medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, and a 401K plan
- Paid leave, including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable
Adecco US, Inc. is an Equal Opportunity Employer/Veterans/Disabled.
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