Senior Director, Quality Operations

cosettepharma; Lincolnton (NC); On-site; USD 130,000 - 160,000; Full time

Job summary

Cosette Pharmaceuticals, Inc., based in Lincolnton, NC, is seeking a Senior Director, Quality Operations. This role involves leading the Quality organization, ensuring compliance with cGMP regulations, and overseeing regulatory inspections.

The ideal candidate will have a Bachelor’s Degree and over 15 years of experience in pharmaceutical quality management. You will be responsible for directing quality assurance activities and overseeing analytical and microbiology lab operations.

Qualifications

• 15+ years of pharmaceutical quality experience in a manufacturing or CMO environment.
• Strong understanding of compliance and regulatory requirements in pharmaceuticals.
• Experience with product development lifecycle including design and validation.

Responsibilities

• Lead the Quality organization and ensure compliance with cGMP.
• Oversee regulatory inspections and maintain quality assurance standards.
• Direct the analytical and microbiology laboratory functions.

Skills

cGMP compliance

Leadership

Analytical proficiency

Microbiological proficiency

Cross-functional teamwork

Education

Bachelor's Degree in life sciences, engineering, or business

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.

Innovating every day.™

Basic Purpose

The Senior Director, Quality Operations will support quality initiatives and ensure compliance with cGMP’s are maintained at the manufacturing facility.

Essential Functions and Responsibilities

• Provides leadership and direction to the Quality organization.
• Provide mentorship, oversight and development for the Quality Assurance, Quality System, Quality Affairs, and Quality Control staff.
• Makes decisions focused on key quality strategic and operational matters that have significant, direction setting impact on the company.
• Directs and controls the activities and outcomes of Quality Assurance which has a significant organizational and product impact.
• Sets and aligns goals and objectives for the Quality Assurance department with the overall corporate goals and objectives.
• Oversee preparation, coordination and execution of all regulatory inspections with the FDA or other regulatory agencies.
• Develop and maintain external relationships with key opinion leaders and regulatory officials.
• Direct the development of systems, practices, and processes to ensure effective ongoing review of product design and/ or manufacturing changes.
• Provide leadership and direction for significant deviation events that may impact compliance status or significant business risk.
• Oversee the functions of the analytical and microbiology laboratory, including:
  • Release of raw materials and components
  • In-process testing
  • Finished product release testing
  • Stability testing
  • Environmental Monitoring
• Review and approve quality documents, including:
  • Deviations
  • Annual Product Quality Reviews
  • Customer Complaints
  • Validation Protocols/Reports
  • Change Controls

Knowledge, Skills, Qualifications and Physical Requirements

Education/Training/Work Experience

• A Bachelor’s Degree or higher degree in life sciences, engineering, or business
• 15+ years pharmaceutical quality experience in a manufacturing, CMO, or life sciences technology driven company.
• Analytical and Microbiological proficiency related to the methodology of semi-solids drug products and associated excipients
• Extensive experience in cGMP and other Regulatory compliance requirements.
• Progressive and proven record of leadership and managing quality/ analytical organization’s establishing long term strategic growth initiatives.
• Experience with phases of the product development lifecycle, including concept, design, implementation, verification, and validation activities necessary for product commercialization.
• Ability to lead, influence, create and work within cross-functional team environments.