Senior Compliance Manager
3 days ago
Job Summary
This role is responsible for leading the quality assurance team in ensuring compliance with regulatory requirements and company standards.
About TalentBurst
TalentBurst is a global company that values innovation, sustainability, and community well-being. We have a strong commitment to promoting healthy living and reducing our environmental footprint.
Key Responsibilities
- Maintain a comprehensive site documentation system and ensure its accuracy and completeness.
- Author and maintain the site Validation Master Plan and ensure compliance with relevant regulations.
- Supervise and manage plant Documentation systems, including SOPs, Management of Change, Notices of Deviation, Batch Records, Nonconformances, and Validations.
- Contribute to the local Automation, Digitization, and Analytics (ADA) strategy, specifically regarding paperless initiatives.
- Develop people, teams, and organizational capabilities through training, information sharing, mentorship, feedback, and delegation.
Required Skills and Qualifications
To be successful in this role, you will need:
- A Bachelor's Degree in Chemistry, Microbiology, Biochemistry, Engineering, or a related field.
- At least 5 years' work experience in a manufacturing plant operating in a Food or Drug/GMP environment.
- Comprehensive knowledge of site-wide documentation systems, Product Release, and Batch record review.
- Familiarity with GMP compliant Failure Investigations, Corrective and Preventive Actions, and Notices of Deviation.
- Leadership skills and experience managing or supporting regulatory inspections.
- Experience with SAP QM, LIMS, or similar integrated computerized systems.
Benefits
TalentBurst offers a competitive salary range of $95,000-$115,000 per annum, commensurate with experience. In addition to a base salary, we provide benefits including:
- Medical, dental, and vision insurance plans.
- A 401(k) retirement plan with company matching contributions.
- Minimum 15 days of vacation/PTO leave annually.
- Paid holidays and sick leave.
- Paid parental leave.
What We Offer
As a Senior Compliance Manager at TalentBurst, you can expect:
- A dynamic and supportive work environment.
- Ongoing training and development opportunities.
- The chance to work on challenging projects and contribute to the company's success.
- A competitive compensation package and benefits.
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