- Develop and implement a comprehensive supplier quality management program designed to address the unique needs of 503A compounding pharmacies, 503B outsourcing facilities, commercial pharmacies, and distribution center operations.
- Collaborate with cross-functional teams, including Operations, Procurement, Quality, and Regulatory to define supplier qualification requirements, quality expectations, performance metrics, and key performance indicators (KPIs).
- Lead supplier quality qualification processes, ensuring that potential suppliers meet quality, regulatory, and business requirements. Works with due diligence team in assessing potential suppliers.
- Conduct thorough risk assessments of suppliers, considering factors such as regulatory compliance, product quality, and business continuity.
- Establish supplier quality agreements outlining expectations, quality standards, reporting mechanisms, and communication channels.
- Implement a defined supplier audit program. May lead or support on-site audits of internal and external suppliers supplier adherence to quality and regulatory standards and Covetrus business requirements.
- Monitor supplier performance through ongoing data analysis, trending, and assessment of quality metrics, taking proactive measures to address potential issues.
- Reports on supplier program and individual supplier metrics and scorecards on a defined cadence and ad hoc as required.
- Collaborate with suppliers to drive continuous improvement initiatives, identifying opportunities for process optimization and quality enhancement.
- Manage Supplier Corrective Action Request activities, ensuring that suppliers adequately investigate and take corrective action on nonconformances and product/service issues.
- Provide training and guidance to internal teams on supplier quality requirements, ensuring a thorough understanding of expectations and processes.
- Bachelor's Degree in scientific (chemistry, biology, etc.) or related field
- Minimum four years of experience in regulated industry
- Minimum two years of direct experience in supplier quality management
- Certified quality auditor or similar industry certification preferred
- Effectively negotiates and builds partnerships throughout multiple organizational levels of business
- Comfortable balancing requirements and delivering outcomes that meet business needs and quality and regulatory requirements
- Experience working in regulated industry (pharmaceutical, compounding, medical device, etc)
- Strong data management skills
- Detail-oriented with strong analytical skills
- Excellent verbal and written communication skills
- Ability to work independently and be self-motivated
- Pet friendly environment
- Extensive computer work
- Business travel (up to 15%)
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Supplier Quality Engineer - Portland, United States - Covetrus
Description
The Supplier Quality Engineer is responsible for establishing and leading a robust supplier quality management program tailored to serve multiple lines of business across North America 503A compounding pharmacies, 503B outsourcing facilities, commercial pharmacies, and distribution centers. The ideal candidate understands the importance of streamlined supplier quality processes, possesses a deep understanding of supplier quality processes and supplier-related regulatory requirements. This position requires prior experience in supplier auditing and has a proven track record of building effective internal and external supplier partnerships. As the Supplier Quality Engineer, you will play a pivotal role in ensuring the quality and compliance of our products and services through rigorous supplier assessment, qualification, and ongoing monitoring.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
QUALIFICATIONS:
EDUCATION AND/OR EXPERIENCE
CERTIFICATES, LICENSES, REGISTRATIONS
COMPETENCIES (SKILLS AND ABILITIES)
PHYSICIAL DEMANDS/WORK ENVIRONMENT
Covetrus is an equal opportunity/affirmative action employer. It does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated with undue hardship, sex, sexual orientation, age, citizenship, marital or veteran status, or any other legally protected status.
Sales Positions are eligible for a Variable Incentive
