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Supplier Quality Assurance Specialist
2 months ago
Corden Pharma Boulder Inc. is dedicated to providing equal employment opportunities to all individuals and prohibits discrimination and harassment of any kind. We value diversity and are committed to fair hiring practices.
As a prominent contract development and manufacturing organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, and drug products, we employ over 2,600 professionals globally. Our mission is to empower pharmaceutical and biotech companies to produce medications that enhance the quality of life.
Our extensive network across Europe and the U.S. delivers tailored solutions through five advanced technology platforms: Peptides, Lipids & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We are committed to excellence in supporting this network and ensuring the highest quality products for patient welfare.
Position SummaryThis role involves collaboration with Quality Assurance to enhance and implement the Supplier Quality Management (SQM) Program, ensuring alignment across all processes related to Supplier Risk Management (SRM).
Key Responsibilities- Lead the development and enhancement of a supplier qualification process that is phase-appropriate, utilizing risk-based tools for evaluation and monitoring.
- Oversee external supplier material performance, ensuring compliance and quality that meet market demands.
- Assess potential new suppliers, conducting evaluations based on audits, quality performance, risk profiles, and business requirements.
- Stay informed on market trends and changes within the CDMO landscape.
- Define and monitor supplier quality management processes and performance metrics, fostering partnerships with suppliers.
- Work with Supply Chain, R&D, Process Engineering, Project Management, and Regulatory Affairs to establish a process for sourcing raw materials.
- Identify and prioritize supplier audits, ensuring adherence to schedules and management of audit outcomes.
- Conduct vendor qualifications by gathering and assessing specification data.
- Communicate effectively with customers and stakeholders regarding quality risks and management.
- Monitor supplier quality and performance, reporting on key metrics.
- Establish and maintain a Supplier Relationship Management (SRM) process focused on continuous improvement.
- Guide the team as a Quality Subject Matter Expert (SME) on supplier-related issues, leading investigations as necessary.
- Ensure timely execution of supplier-initiated changes and coordinate with Supply Chain for inventory management.
- Collaborate with suppliers to enhance partnerships and prepare for future growth.
Provide leadership in managing and improving the Supplier Quality Management Program across manufacturing sites.
QualificationsTo succeed in this role, candidates should possess a Bachelor's degree (BS) with a minimum of 10 years of relevant experience, or an equivalent combination of education and experience in a manufacturing environment. Experience in Supplier Management and Quality Auditing is preferred. Familiarity with ERP systems such as SAP and proficiency in Microsoft Office Suite is essential.
Core Competencies- Experience in pharmaceutical/biopharmaceutical/chemical manufacturing processes and related Quality Assurance.
- Strong knowledge of cGMP, GLP, FDA Guidelines, and industry standards.
- Excellent analytical, organizational, and problem-solving skills.
- High level of interpersonal and negotiation skills.
- Proficient in computer systems, including word processing and spreadsheets.
- Strong written and verbal communication skills.
- Commitment to high ethical standards in business practices.
- 401(k) matching
- Health Insurance
- Life Insurance
- Paid Maternity/Paternity Leave
- Tuition Reimbursement
- Wellness Program
- Vacation
