Haleon
Inspection Readiness Specialist
USA - New York - Oak Hill
Sponsorship not specified$110k-$151kDetected 13 days ago
Project ManagementAuditingGMPFDA RegulatoryLeadershipCommunicationProblem SolvingAdaptabilityInternal Audit
About the role
- We're a purpose-driven, world-class consumer company putting everyday health in the hands of millions.
- In just three years since our launch, we've grown, evolved and are now entering an exciting new chapter - one filled with bold ambitions and enormous opportunity.
- What sets us apart is our unique blend of deep human understanding and trusted science.
Responsibilities
- Manage and Support FDA and other regulatory inspections for the site
- and manage completion of commitments.
- write and coordinate the issuance of a timely response for any observations, including follow-up reports. Manage internal commitments to ensure timely follow-up and completion as committed to the audit functions.
- Maintain Site Internal Audit and Self-Inspection programs.
- Approve GMP related documentation such as SOPs, CCs, Deviation, Validation/Qualification documents and Technical Reports. Approves any changes associated with these documents.
- Manage and Support FDA and other regulatory inspections for the site; write and coordinate the issuance of a timely response to the Agency for any observations; and manage completion of commitments.
- Host Internal Corporate; write and coordinate the issuance of a timely response for any observations, including follow-up reports. Manage internal commitments to ensure timely follow-up and completion as committed to the audit functions.
- Demonstrate initiative and analytical problem-solving skills - ability to use and interpret data to drive decision making at both tactical and strategic level.
- This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees.
Requirements
- Bachelor's degree in science or relevant field and 5 years of experience in a regulated GMP industry
- Excellent verbal and written communication skills required.
- Conflict resolution and interaction management skills required
Compensation
- The salary range for this position is $110,178 to $151,494.20 plus a 12% Performance Bonus
Benefits
- Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program.
- This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave.
- On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family.
- We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.
- There is a range of educational experience allowed based on pharmaceutical experience obtained:
- Must be flexible, adaptable, and a strong team player and a leader that fosters teamwork and promotes Company Values, Behaviors and Strategies.
Equal opportunity
- Job Accommodation Request'
- Your Name and contact information
- Requisition ID and Job Title you are interested in
- Location of Requisition (city/state or province/country)
This listing is sourced directly from Haleon's careers page and normalized into a canonical job model.