What are the responsibilities and job description for the Quality Manager position at Confidential?
Quality Manager
The Quality Manager provides strategic leadership and oversight for all Quality Assurance programs, ensuring compliance with FDA regulations, current Good Manufacturing Practices (cGMP), and company quality standards. This role is responsible for managing the Quality Management System (QMS), leading the Quality Assurance team, overseeing product quality throughout the manufacturing process, and ensuring the safety, identity, strength, purity, and quality of pharmaceutical products.
Key Responsibilities
- Lead, supervise, mentor, and develop the Quality Assurance team, including hiring, training, coaching, and performance management.
- Oversee the Quality Management System (QMS) and the daily operations of the Quality Assurance department.
- Ensure compliance with FDA regulations, cGMP requirements, and internal quality standards.
- Release raw materials, packaging components, in-process materials, and finished products.
- Develop and implement quality improvement initiatives that support business objectives and regulatory compliance.
- Establish inspection standards and quality metrics.
· Administer internal audit programs to verify compliance with cGMP and regulatory requirements.
· Review and approve Master Batch Records, Standard Operating Procedures (SOPs), Validation protocols, Quality documentation, etc.
- Lead the Change Control Committee, ensuring all facility, equipment, process, product, and documentation changes are properly reviewed, assessed, documented, and approved.
- Maintain the confidentiality of proprietary, regulatory, and quality-related information.
Required Qualifications
- Bachelor's degree in Chemistry, Biology, Pharmacy, or another related scientific discipline.
- Minimum of five years of management experience in Quality Assurance, preferably within the pharmaceutical industry.
- Extensive knowledge of FDA regulations and current Good Manufacturing Practices (cGMP).
- Experience with Quality Management Systems (QMS), document control, audits, inspections, and change control processes.
- Strong leadership, communication, organizational, and problem-solving skills.
- Ability to handle confidential information with professionalism and discretion.
Ideal Candidate
The ideal candidate is an experienced pharmaceutical quality professional who combines strong leadership with extensive regulatory expertise. They are highly organized, detail-oriented, and capable of managing multiple priorities while maintaining the highest standards of product quality and regulatory compliance. They foster a culture of continuous improvement and are committed to ensuring the consistent production of safe, effective, and high-quality pharmaceutical products.
Job Type: Full-time
Pay: From $90,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
Salary : $90,000