Senior Director, Quality Operations

Cosette Pharmaceuticals, Inc.; Lincolnton (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Cosette Pharmaceuticals, Inc. is seeking a Senior Director, Quality Operations to lead quality initiatives and ensure cGMP compliance at the North Carolina manufacturing facility.

You will oversee Quality Assurance, Quality Systems, Quality Affairs and Quality Control, directing regulatory inspections and maintaining external relationships with regulators and key opinion leaders. Responsibilities include setting goals for QA, guiding deviation handling, document review, and overseeing analytical

Qualifications

• A Bachelor's Degree or higher degree in life sciences, engineering, or business.
• 15+ years pharmaceutical quality experience in manufacturing, CMO, or life sciences tech.
• Analytical and Microbiological proficiency related to semi-solids drug products.
• Extensive experience in cGMP and regulatory compliance.
• Proven leadership and ability to drive strategic growth in quality.

Responsibilities

• Provides leadership and direction to the Quality organization.
• Mentors and develops QA, Quality System, Quality Affairs, and QC staff.
• Leads key quality strategic and operational decisions with company impact.
• Oversees regulatory inspections with FDA or other agencies.
• Directs development of systems and processes for change controls and reviews.
• Oversees analytical and microbiology labs: release/testing, stability, EM.

Skills

Leadership

Cross-functional teamwork

Analytical proficiency

Regulatory compliance

Quality management

Education

Bachelor’s degree or higher in life sciences/engineering/business

Job description

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.

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.

Equal Opportunity Employment

Cosette Pharmaceuticals, Inc. is committed to providing equal employment opportunity to all applicants and employees in all phases of our operations. It is the policy of this Company that there shall be no discrimination with respect to employment, or any of the terms and conditions of employment, because of an individual’s race, creed, religion, color, national origin, citizenship, ancestry, age, sex, pregnancy, childbirth or related medical conditions, gender identity or expression, sexual orientation, marital status, domestic partnership, familial status, reproductive health decisions, status as a victim of domestic violence, stalking, or sexual assault, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, veteran status, liability for service in the United States armed forces, or any other legally protected status. The Company is dedicated to ensuring that all employment decisions are in accordance with these principles of equal employment opportunity.