Job Description Summary

Summary of Position

The Senior Quality Specialist, Compliance & Supplier Quality is responsible for independently owning, planning and conducting activities that ensure the supplier management program for PAR Health meets cGMPs and regulations as well as internal quality procedures/governance. The Supplier Quality Specialist is accountable for ensuring that materials, components, and services provided by suppliers meet company quality standards and regulatory requirements. This role works cross functionally with procurement, quality, engineering, and suppliers to drive continuous improvement, resolve quality issues, and maintain a robust supplier quality management system. . Owns material non-conformance program and end-to-end supplier initiated changes (SIC) to completion.

Provides SME consultative support for all regulatory audits, internal and external inspections and other audits. Leads cGMP projects for continuous improvement to ensure compliance with regulations and current industry standards. Implements a self-inspection program and evaluates metrics to determine trends and opportunities for continuous improvements and liaises with QS&T and other departments.
Maintains and communicates monthly metrics to site leadership.

Job Description

Responsibilities
• Independently evaluates supplier quality documentation to determine acceptability and compliance with applicable requirements.
• Independently manages the resolution of supplier quality issues and identifies opportunities for improvement.
• Drives the timely receipt and approval of acceptable quality documentation from suppliers.
• Manages supplier documentation requirements and assesses supplier TUP questionnaires.
• Ensures adherence to applicable SOPs, policies, regulations, and quality standards.
• Ensures procedures accurately reflect current practices, regulatory requirements, and industry guidance.
• 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.
• Actively evaluates quality and supplier performance metrics to identify trends, risks, and opportunities for continuous improvement.
• 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).
• Performs other duties as assigned.

Minimum Requirements
• BA/BS preferably 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.

Relationship with Others/Scope of Position

Knowledge
• Proficiency in a body of information required for the job
• e.g. 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
• Strong 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:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.