Principal Supplier Quality Specialist
hace 7 días
North Billerica
Job DescriptionDescription: SHINE SPECT is seeking a Principal Supplier Quality Specialist to serve as a senior-level quality expert responsible for developing, enhancing, and executing the Supplier Quality Management (SQM) program to ensure robust controls, processes, and procedures across the global supply base. The Principal Supplier Quality Specialist ensures compliance with global regulatory requirements (FDA, EMA, ICH, ISO) and alignment with pharmaceutical industry best practices. The Principal Supplier Quality Specialist partners closely with Procurement, Quality Assurance, Manufacturing, and External Manufacturing to ensure that materials, components, and services consistently meet quality, safety, and performance expectations. This position is based in Massachusetts and requires presence on-site three days per week. The base salary range for this position is $130,000-$150,000 per year plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location. Duties and Responsibilities: Supplier Qualification & Oversight • Serve as the technical lead, and continuously improve, the qualification program for suppliers, contractors, and service providers, ensuring comprehensive assessment of quality systems, technical capabilities, and compliance history., • Conduct, coordinate, and/or oversee GMP and quality system audits as the lead auditor., • Maintain the Approved Supplier List (ASL) and ensure supplier status information is current, accurate, and compliant., • Establish and support monitoring of supplier performance metrics (KPIs/SLAs) related to quality, compliance, delivery, and responsiveness., • Lead supplier performance reviews and drive collaborative continuous improvement initiatives., • Draft, negotiate, revise, and maintain Quality Agreements defining roles, responsibilities, and quality requirements., • Manage the Supplier Change Notification process, ensuring timely internal evaluation, risk assessment, and implementation of controls., • Serve as the lead for the Supplier Corrective Action Request (SCAR) process, ensuring thorough investigations, root cause analysis, and effective CAPA implementation., • Track SCAR performance and verify the long term effectiveness of corrective actions., • Support External Manufacturing (ExM/CMO) operations by evaluating supplier issues that impact externally manufactured products., • Review, assess, and approve supplier related deviations and CAPA, ensuring alignment with cGMP and internal requirements., • Ensure supplier related processes, documentation, and oversight practices comply with cGMP, ICH, and global regulatory requirements., • Act as the subject matter expert during regulatory inspections and customer audits for supplier quality and the SQM program., • Monitor industry trends and regulatory changes to ensure the SQM program remains current and best in class., • Technical Leadership & Cross Functional Influence., • Serve as a senior technical expert and thought leader in Supplier Quality Management., • Lead cross-functional improvement initiatives and supplier-related quality governance activities., • Serve as a senior technical expert and thought leader in Supplier Quality Management., • Lead cross-functional improvement initiatives and supplier-related quality governance activities., • Influence organizational decisions using deep expertise in supplier risk, compliance, and quality systems.Requirements:, • Bachelor’s degree in Engineering, Life Sciences, Chemistry, Pharmacy, or a related field; advanced degree preferred., • 10+ years of experience in pharmaceutical or biotechnology Quality Assurance, with substantial focus in Supplier Quality Management, Supplier Auditing, and/or External Manufacturing oversight., • Deep knowledge of global regulatory requirements and pharmaceutical GxP standards, including FDA, EMA, MHRA, PMDA, ICH, and PIC/S., • Extensive experience conducting GMP supplier audits (API, excipients, packaging, contract labs, service providers), with the ability to independently plan, execute, and close domestic and international audits., • Strong background in Quality Management System (QMS) auditing, including data integrity, change control, raw material qualification, deviation investigations, and CAPA effectiveness., • Demonstrated experience managing Quality Agreements, assessing supplier change notifications, and leading SCAR/CAPA processes., • Experience supporting regulatory inspections as an SME for supplier quality or the SQM program., • Excellent analytical, communication, and cross functional influencing skills, with proven ability to navigate complexity in a global environment., • Domestic and international travel to suppliers will be required based on business needs., • Preferred Certifications & Training, • ASQ Certified Quality Auditor (CQA) or equivalent auditing credential., • ASQ Certified Supplier Quality Professional (CSQP) or Certified Quality Engineer (CQE)., • ISO 9001 Lead Auditor, ISO 13485 Auditor, or similar auditor training., • Training in GMP/GxP auditing, ICH Q7/Q9/Q10, root cause analysis, and CAPA management., • Six Sigma Green Belt or Black Belt certification SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions. SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Pay Transparency Policy Employee Rights Under the NLRA Equal Opportunity Employment