Sr. Specialist, Supplier Quality Management

Responsibilities

• Negotiates suppliers Quality Agreements commitments prior to QRA Management approvals (by ensuring preparation of the adequate documentation)
• Evaluates suppliers in compliance with Good Manufacturing Practices and regulatory requirements
• Ensures CAPAs for which the team is responsible are followed and closed within defined timelines
• Reviews, comments and challenges in an appropriate way, the Quality Reviews for the supplier’s quality agreements status
• Understands technical supplier issues and evaluates their potential impact on product quality and compliance
• Escalates complex issues to management in a timely manner
• Prioritizes and ensures work is delivered in an efficient way
• Represents QA in meetings related to his/her area of responsibility (suppliers meeting, change control, audits planning and review, budget, etc.)
• Addresses CAPA’s from external audits
• Conducts a management review (for suppliers) of the quality system
• Follows-up on and closes pending preventive and corrective action requests

Qualifications

• 2-4 years of experience preferred
• Bachelor’s, Master’s or equivalent experience in related field preferred
• Knowledge of supplier quality /quality systems and approaches
• Understanding of relevant FDA regulations, standards and operating procedures for supplier qualifications
• Knowledge of Supplier Quality as it relates to pharmaceutical products
• Manage the supplier risk assessments and quality agreements for all Private Label suppliers and services
• Demonstrates knowledge of Quality System processes for suppliers
• Understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, auditing, CAPA and problem solving
• Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements