Specialist, Supplier Quality

About the Company

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. The company has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions, and suppositories, leading to consistent supply to customers and commercialization success. Cosette operates corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.

About the Role

This position is responsible for maintaining the Cosette Supplier Management Program under the direction of Supplier Quality Management. The role requires strong influencing skills, risk-based decision-making capability, and a high degree of collaboration and teamwork. The position will support the supplier quality team in collaborating with cross-functional teams to onboard new suppliers and maintain current suppliers.

Responsibilities

• Drive and maintain the Cosette Supplier Management Program, including:
  • Supplier records and supplier CAPA
  • Audits and reporting
  • Risk assessments
  • Creation and updating of quality agreements
  • Performance and support of supplier audits
• Collaborate with cross-functional teams to onboard new suppliers and maintain current suppliers.
• Maintain metrics for adherence to the supplier audit schedule.
• Participate in internal, customer, and regulatory audits as needed.
• Support projects as requested.
• Travel up to 25%.

Requirements

• Bachelor’s Degree in a scientific/technical discipline; advanced degree preferred.
• 3+ years of experience in the pharmaceutical/regulated products industry, with a focus on Quality Control and Quality Assurance.
• Support of Regulatory Agency (FDA, EMA) Inspection Experience preferred.

Skills

• Technical Writing
• Functional Knowledge:
  • Analytical Methods
  • Root Cause Techniques
  • CAPA System
  • GMP Training
  • Quality Management Review
  • Validation Practices
  • Data Integrity
• Industry Related Knowledge:
  • Quality Management Systems
  • Analytical Chemistry
  • External Vendor Auditing Experience preferred
• Experience with MS Word, Excel, and Project.
• Experience with eQMS required.
• Experience with document control/management in a regulated environment.
• Fundamental knowledge of quality systems in regulated environments.
• Skilled at organizing information into a clear, concise written form and the ability to write for compliance.
• Customer-focused, initiative, and interdependent partnering.
• Good organizational and planning skills.
• Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation.
• In-depth understanding of good documentation practices in a GMP environment.
• Ability to make and guide quality/compliance decisions that are data-based and commensurate with risk.

Pay

The expected annual base salary for this New Jersey-based position is $102,000 - $128,000. In addition, you may be eligible for a discretionary bonus if you are an active employee on the payment date.

Benefits

• Medical, dental, and vision insurance
• Life insurance
• Short-term and long-term disability
• 401(k) match
• Flexible spending accounts
• Health savings account
• Employee assistance program
• Tuition reimbursement program
• Parental leave
• Wellness program
• Paid time off
• Volunteer time
• Holidays

Schedule

This role follows a hybrid work schedule, requiring three (3) onsite days per week at the Bridgewater, NJ office.