New · posted Oct 15
Exela Pharma · Pharmaceuticals
Director, Quality Operations
- Lenoir, NC
- On-site
- Full-time
- Director
Open until filled
The role
The Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position is ultimately responsible for the product quality received by the customer and the quality system integrity expected by the customer. The Quality Director is committed to relentlessly pursuing zero defect manufacturing and maintaining strong and efficient conformance to all quality expectations and compliance with all regulatory standards. This position is the decision maker for the Quality Management System deployed throughout the company. The Quality Director will oversee the health of the manufacturing processes through risk monitoring and oversee the conformance to the QMS through internal audits and management review. In addition, the Quality Director will represent the company as the Quality Representative for all external audits. This position will support sales and marketing to convey the company passion for quality to new and prospective customers. Key metrics: Customer Satisfaction, Audit non-conformances, Regulatory Compliance, Cost of Quality, Validation on Time.
What you need
Education Requirements
- Bachelor’s Degree in a scientific discipline required and A minimum of ten (10) years working experience in the medical or pharmaceutical manufacturing industry is Required. In addition, a minimum of five (5) years prior management experience Preferred.
Experience Requirements
- Strong communicator with an ability to provide clear directions to the company.
- Possess a passion for results and company performance.
- Must set the expectation for the company in quality mindfulness and lead by example.
- Must be able to sit and/or stand for extended periods of time.
- Must be able to climb stairs, must be able to lift and carry 25 lbs. and walk while carrying items.
What you'll do
- Direct the day-to-day responsibilities and duties of personnel within the quality department.
- Perform manufacturing investigations, writing investigation reports, and facilitating corrective and preventive actions including:
- Provide management oversight for quality control, batch records, and material review board.
- Provide management oversight for all QMS documents and change control.
- Ensure adherence to procedures.
- Collaborate with department heads to ensure QMS supports the company needs and is efficient for the employees.
- Serve as the company Quality Representative for ISO 13485, 21 CFR part 820, 21 CFR part 4, and all associated regulatory requirements.
- Drive risk management in design, validation, and ongoing manufacturing.
- Ensure strong and efficient process validations to ensure manufacturing success.
- Drive strong internal audit program and robust management reviews.
- Drive strong quality performance and continuous improvement:
- Customer Complaints
- CAPA effectiveness
- Cost of Quality with a focus on First Pass Yield and Scrap.
- Completion on time for CAPA, Internal Audits, Management Review
- Audit non-conformances
- Perform other duties as assigned.
Where you'll work
Lenoir, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Lenoir, NCJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $186,500 | $209,250 | $231,375 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Exela Pharma's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk6
- GMP and compliance4
- Collaboration and leadership4
- Documentation and SOPs3
- Investigations and CAPA3
- Validation and qualification3
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Exela Pharma on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Quality3 100%
By level
- Manager2 67%
- Director1 33%
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Director, Quality Operations at Exela Pharma
Open until filled.