Specialist, Supplier Quality

Cosette Pharmaceuticals Inc.; Bridgewater (MA); Hybrid; USD 102,000 - 128,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Short-term disability

Long-term disability

401(k) match

Flexible spending accounts

Health saving account

Employee assistance program

Tuition reimbursement

Parental leave

Wellness program

Paid time off

Volunteer time

Holidays

Job summary

Cosette Pharmaceuticals, Inc. is seeking a supplier quality professional responsible for maintaining the Cosette Supplier Management Program. You will collaborate with cross-functional teams to onboard new suppliers and maintain current supplier relationships.

The role emphasizes risk-based decision making, CAPA, audits, and documentation control in a GMP environment. Travel up to 25% is required to support internal, customer, and regulatory audits.

Qualifications

• Bachelor’s degree in a scientific/technical discipline.
• 3+ years in pharma/regulated products with QA/QC focus.
• Experience supporting FDA/EMA inspections preferred.

Responsibilities

• Maintain Cosette Supplier Management Program and related records.
• Lead supplier audits, CAPA, and reporting.
• Create and update quality agreements.
• Collaborate with cross-functional teams to onboard/maintain suppliers.
• Monitor metrics for audit adherence.
• Support internal, customer, and regulatory audits.
• Travel up to 25%.

Skills

Technical Writing

Risk Assessment

GMP Knowledge

Data Integrity

Regulatory Inspection

Education

Bachelor’s Degree in a scientific/technical discipline

Advanced degree preferred

Tools

eQMS

MS Word

MS Excel

MS Project

Document Control Systems

Job description

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. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.

Position Summary

This position is responsible for maintaining Cosette Supplier Management Program under the direction of Supplier Quality Management. Position 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.

Key Responsibilities

• Drive and maintain the Cosette Supplier Management Program to include the following:
  • Supplier records and supplier CAPA
  • Audits and reporting
  • Risk assessments
• Create and update quality agreements
• Perform/support 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%

Qualifications

Education and Experience

• 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

Specialized Knowledge and 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, 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.

Salary Range

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

Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, health saving account, employee assistance program, tuition reimbursement program, parental leave, wellness program, paid time off, volunteer time, and holidays.

Physical Requirements

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