Director of Quality – 503B facility

The Director of Quality oversees Quality Assurance, Quality Control, and Compliance functions at the Dyersburg TN site. The Director of Quality provides strategic leadership and oversight of the Quality Management System (QMS) for a 503B outsourcing facility engaged in sterile and non-sterile compounded drug products. This role ensures full compliance with FDA 21 CFR Parts 210/211, Section 503B of the FD&C Act, USP <795>/<797>/<800>, applicable cGMPs, and state board of pharmacy requirements. The director will lead and manage the strategic and operational performance of Quality function for the site; guide, coach and lead staff ensuring the successful day to day management of Quality activities, Key Performance Indicators (KPIs) and company objectives, whilst adhering to regulatory compliance and achieving commercial success. The Director of Quality is responsible for maintaining a strong culture of quality. The director will manage quality metrics, scorecard and implement continuous improvement programs.

This is an on-site position in our 503B outsourcing facility in Dyersburg, TN.

ESSENTIAL DUTIES AND RESPONSIBILITIES

· Lead the site Quality organization to ensure compliance with cGMP, 503B guidance, USP requirements, state pharmacy regulations, and internal quality standards.

· Maintain inspection readiness at all times; lead FDA, state, customer, and third-party audits, including preparation, hosting, response development, and follow-up actions.

· Serve as the senior onsite quality authority for decision-making, escalation management, and product disposition.

· Oversee all core Quality Systems, including change control, deviations, CAPAs, investigations, complaints, document control, training, supplier qualification, and Annual Product Reviews.

· Ensure robust data integrity practices and adherence to ALCOA principles across all departments.

· Utilize quality metrics and trend reporting to evaluate system performance and drive continuous improvement.

· Effectively direct and manage resources within Quality to advance to achieve corporate objectives

· Lead Documentation control (master batch record, specification & method), Batch record review, product disposition, microbiology related operation, investigations, complaints, deviations, CAPAs, APRs, GMP training, Validation /qualification development, execution and approval

· Partner closely with Operations, and Regulatory to ensure aligned quality and business objectives.

· Support production activities through timely batch record review, release decisions, and oversight of sampling, testing, and AQL inspections.

· Collaborate on new product introductions, process improvements, and technical projects to ensure quality requirements are met.

· Proactively develop strategies to address issues and find solutions that move projects forward

· Maintain and improve Quality function’s operational performance, to meet the requirements of regulatory authorities, company standards, SOPs and external and internal customers, with respect to quality, service, lead time and cost.

· Lead Quality Risk Management (QRM) activities to identify, assess, and mitigate product and process risks in alignment with regulatory expectations.

· Anticipate potential compliance or operational issues and provide practical, risk-based solutions to maintain product quality and workflow continuity.· Collaborate with ops, regulatory, purchasing, sales and marketing and other departments of the organization and other sites to achieve common quality and business goals.

· Implement and refine systems, processes, and organizational structure to enhance efficiency, compliance, and operational performance.

· Drive initiatives focused on reducing deviations, improving batch review cycle time, and strengthening sterility assurance fundamentals.

· Other duties may be assigned by the company.

Education And Experience

· Bachelor's degree in a Microbiology, Chemistry or related life sciences

· 7 – 10 years of experience in a pharmaceutical environment, in Quality Operations, with regulatory inspection experience; 5 years leading, and managing staff

· Expertise in Microbiology and hands-on management of micro-related investigations

· Strong understanding of aseptic processing, microbiology, and cGMP expectations for sterile drug products.

· Extensive knowledge of cGMP, Board of Pharmacy requirements, DEA requirements

· Previous experience in 503B outsourcing operation is required

· Excellent communicator and ability to work in a matrix organization

· Demonstrated experience leading quality compliance for commercial products, including regulatory inspections

Qualifications/Skills

• Analytical and problem-solving skills
• Continuous improvement and simplification of processes
• Hands-on experience in QA, QC and Compliance functions and hosting regulatory inspections
• Leadership in managing staff and working effectively with other sites of the organization
• Strategic Planning and Project Management

Job Type: Full-time

Pay: From $140,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Application Question(s):

• Do you have a bachelor's degree in a Microbiology, Chemistry or related life sciences? Required
• Do you have 7 – 10 years of experience in a pharmaceutical environment, in Quality Operations, with regulatory inspection experience? Required
• Do you have a strong understanding of aseptic processing, microbiology, and cGMP expectations for sterile drug products?
• Do you have demonstrated experience leading quality compliance for commercial products, including regulatory inspections? Required
• Are you an excellent communicator and ability to work in a matrix organization? Required
• Do you have hands-on experience in QA, QC and Compliance functions and hosting regulatory inspections? Required.
• Leadership in managing staff and working effectively with other sites of the organization? Required .

Education:

• High school or equivalent (Preferred)

Experience:

• leading, and managing staff: 5 years (Required)
• Previous 503B outsourcing operation : 5 years (Required)

Work Location: In person

Salary : $140,000