Quality Compliance Specialist

The Quality Compliance Specialist supports quality compliance systems and objectives within the site.  Responsible for conducting the internal audits and the CAPA Tracking.  Participates in the Inspection Readiness Team, assessment of compliance with domestic, foreign and corporate regulations, guidelines and policies relevant to Good Manufacturing Practices.   Perform External Audits to Suppliers as needed, handle and assist Site QO during regulatory inspections, fulfil request to support regulatory registration submissions and post approval CMC.  Assure site adherence to FDA among other worldwide regulatory agencies. Approver of Complaint investigations and Annual Product Review Report, contributor and approver as well as SOPs.

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

• Lead auditor for Independent Business Monitoring program (internal audit)
• Manages site audit plan, including issuing audit reports and communication to managers; tracks audit commitments and manages monthly reporting.
• Develops, implements, and ensures completion of site Integrated Audit Plan for external and regulatory inspection, providing monthly status update to Quality Council.
• Assist in Field Alert Report preparation as needed.
• Participates in walk-throughs, IR Gembas and PAI 
• Assists in the preparation for and participation in regulatory agency inspections, corporate and customer audits, including audit readiness assessments.
• Acts as scribe/ monitor or strategist for FDA/DEA, foreign and/or third-party site inspections.
• Manages audit follow-up, including participating in root cause analysis (where required), reviewing and agreeing CAPA plan and monitoring CAPA effectiveness.
• Participates/assist/write inspections responses.
• Keeps tracks of regulatory commitments and site inspection response commitments monitoring for timely completion. 
• Stays current with all relevant Federal, state, foreign, and corporate regulations, guidelines, and policies and industry trends.
• Analyses and interprets compliance information independently.
• Provides documentation for filing as requested by GMC or market RA to support submissions or renewals.
• Support response to queries from regulatory agencies for regulatory filings or product license renewals, as needed.
• Site licenses/ registration submission and renewals (pharmaceutical industry registration, FDA, Food Facility Registration, etc.) on time.
• Handles regulatory queries from different markets.
• Review and approval of complaints; assist in coordination of complaints program and trending of complaints as needed.
• Generate and approve Product Record Review data contribution.
• Supports manager in the preparation of presentation, minutes and action logs of the Quality Council meetings.
• Work together with the team to assure that QO objectives goals are met.
• Keep appropriate site/corporate management informed of compliance status via Real Time Notification and Product Incident Management,
• Review and approve commitment actions.
• Participate as Subject Matter Expert (SME) for SOPs review and approval.
• Assist in the review of risk assessments for projects/suppliers’ audits, quality agreements review and suppliers' documentation.
• Provide trainings as needed.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Associate’s degree in science (biological sciences, chemistry, pharmacy or related scientific discipline)
• Experience in Pharmaceutical Quality Assurance and Quality Compliance

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Bachelor’s degree preferred
• Certified auditor preferred
• 5 years’ experience in a GMP environment.
• Previous experience on systems
• Working knowledge of pharmaceutical facilities, equipment and systems.
• Highly effective oral and written communication skills.
• Knowledge of QMS, cGMPs, and other relevant standards.
• Computer literacy with the ability to compile and generate graphs and key performance metrics in MS Office Suite or comparable software 

The salary range for this role is:  $80, 791 – $111,088 annually.

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.

Accommodation Requests 

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please contact us by sending an email to HR.AmericasSC-CS@haleon.com. Please include the following in your email: 

• Use subject line: ‘Haleon Careers: 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) 

• Description of specific accommodation you are requesting 

• Resumes, CVs, or other requests outside of accommodation support submitted to this email box will not be accepted.   

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.