QA Manager, Quality Systems & Supplier Management (Remote)

About the role

The QA Manager, Quality Systems & Supplier Management is primarily responsible for the organizations supplier quality activities and audit programs to ensure compliance with applicable regulatory requirements, industry standards, and internal procedures. This role plays a critical leadership function in driving continuous improvement, ensuring product quality, and managing supplier performance across the supply chain.

Essential Duties

• Supports Companys Mission and Vision statement by adhering to the Code of Corporate Values and conforming to established performance expectations.
• Supports Director of QA Compliance in setting and implementing internal/external quality requirements to ensure company's products and/or services from external domestic and international Suppliers and/or CMO's meet cGMPs and company's and customer expectations by:
• a. Identifying and implementing effective quality control systems at the supplier sites to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
• b. Ensuring suppliers are compliant with all regulatory and the company's requirements.
• c. Supporting supplier management team in identifying opportunities for improvements.
• d. Proactively investigating, identifying, and implementing best-in-class supplier quality practices.
• e. Providing technical mentorship and resolving quality supply chain issues with suppliers.
• f. Providing Quality support and technical expertise to cross-functional groups and personnel on projects, as appropriate.
• g. Reviewing documents including standard operating procedures (SOPs), protocols, deviations, CAPAs, reports, and other GMP documents as required.
• h. Filing and maintaining controlled documents.
• Conducts external cGMP, Pharmacovigilance or for cause audits of third parties and/or partners to ensure supplier quality-related activities related to business partners, contracted labs, manufacturers, and distribution warehouses performance meets quality system requirements, and that those requirements are effectively established and maintained in accordance with cGMP, other worldwide regulations, as applicable, and company’s Quality Management System by:
• a. Performing site inspections to drive improvement in supplier performance.
• b. Auditing, evaluating and qualifying new suppliers in accordance with audit plans developed by/with the Manager of QA Supplier Quality.
• c. Reviewing and evaluating supplier’s audit response against current industry standards and guidelines to assure sufficient controls are in place by the supplier to meet specifications and quality requirements.
• d. Following up on prior audit recommendations to ensure implementation and compliance.
• e. Creating, revising and maintaining supplier quality standard operating procedures.
• Maintains supplier quality and safety data exchange agreements and schedules.
• Maintains the approved supplier list, supplier scorecard, and supplier audit schedule.
• Supports Director of QA Compliance in ensuring compliance with applicable quality management system requirements, engaging in supplier corrective actions as needed.
• Actively monitors supplier quality metrics.
• Actively participates in supplier quality related communication and feedback.
• Supports site regulatory inspections; interface with Regulatory Agencies during inspections.
• Makes sure to monitor, elevate, and report metrics on cGMP systems by:
• Performing/documenting customer complaint investigations, as needed
• Preparing trend reports related to company’s supplier quality systems.
• Managing audit CAPAs to ensure that corrective and preventive actions are completed on time.
• Assists with investigations and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.
• Participates and supports internal audits, client audits and FDA inspections.
• Analyzes compliance metrics, and identifies potential improvement activities.
• Communicates issues/trends to Director of QA Compliance.
• Aids in management and coordination of site activities for Field Alerts, Recalls and other market actions.
• Performs other related duties as assigned or directed.

Basic Qualifications

• Education: Bachelor’s degree in science or Regulatory Discipline.
• Experience: Minimum: 8 years / Proficiency: 10 years

Skills

• GMP Compliance, Auditing, FDA, and other regulatory agency requirements including, but not limited to batch disposition, change controls, PV, CAPA, deviations etc.
• Internal/external audits, Quality Management Review.
• Basic/Moderate/Proficient reading, writing, grammar, and mathematics skills
• Basic/Moderate/Proficient interpersonal relations and communication skills, including use of English language.
• Basic Moderate/Proficient computer skills including Microsoft Office, Go To Meeting

Travel

25%