Sr. Quality Specialist, Compliance & Supplier Quality

Job Description

The Senior Quality Specialist, Compliance & Supplier Quality plays a crucial role in ensuring that PAR Health's supplier management program adheres to cGMPs and regulations, as well as internal quality procedures and governance. This role involves managing supplier quality issues, driving continuous improvement, and supporting regulatory inspections.

• Evaluates supplier quality documentation to ensure compliance with applicable requirements.
• Manages supplier documentation requirements and assesses supplier TUP questionnaires.
• Ensures adherence to applicable SOPs, policies, regulations, and quality standards.
• Serves as a subject matter expert (SME) and provides consultative support for regulatory inspections, internal and external inspections, and other audits.
• Supports the development, implementation, and maintenance of the facility FDA Readiness Plan.
• Partners with Supply Chain and Site Quality to ensure manufacturing needs are met while maintaining quality and compliance requirements.
• Partners with Technical Operations and Site Quality to execute the TUP program.
• Owns and leads the end-to-end Supplier Performance and Supplier-Initiated Change programs.
• Evaluates, qualifies, and monitors suppliers to ensure compliance with company requirements and applicable industry quality standards.
• Owns and leads the end-to-end Nonconformance Material Review (NCMR), Corrective and Preventive Action (CAPA), and Supplier Corrective Action Request (SCAR) programs.
• Implements and manages a self-inspection program; evaluates metrics to identify trends, risks, and opportunities for continuous improvement and collaborates with QS&T and other departments as appropriate.
• Leads cGMP projects and continuous improvement initiatives to ensure compliance with applicable regulations and current industry standards.
• Drives continuous improvement initiatives with suppliers and across facility quality programs.
• Travels to supplier locations, as necessary, to expand technical and operational knowledge and support supplier investigations.
• Maintains and communicates monthly quality and supplier performance metrics to site leadership.
• Leads the monthly Material Review Board (MRB).

Minimum Requirements

• Bachelor's Degree (BA/BS) in Life Sciences with a minimum of 6+ years' relevant experience in the pharmaceutical industry, or
• Master's Degree in Life Sciences with 4+ years' experience in the pharmaceutical industry.

• Minimum 4+ years in Quality and/or supplier management role.

Knowledge Proficiency

• Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
• Strong knowledge of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, and DEA.
• Knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines.
• Technical and quality background related to pharmaceuticals.
• ERP system experience required, SAP experience preferred.
• Experience with electronic change management system preferred.

Skills & Abilities

• Ability to drive projects to completion and/or support cross-functional projects.
• Strong written and oral communication skills.
• Strong focus on quality and proven ability to apply a high degree of integrity.
• Customer/Stakeholder focused (understand business plans and operating environment).
• Technical Writing ability.
• Clear problem-solving and decision-making skills.
• Ability to work independently with minimal oversight and appropriately represent company to suppliers, business stakeholders, etc.
• Advanced Excel/data analysis skills required.

Physical Requirements

• Walk across plant/warehouse.
• Business travel up to 10%.

Disclaimer

• We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law.

EEO Statement

• We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law.