Job Summary The Senior Manager, Quality Operations is accountable for driving results in a fast ... Provides direct support and leadership during site regulatory inspections to ensure minimal ...
Job Summary The Senior Manager, Quality Operations is accountable for driving results in a fast ... Provides direct support and leadership during site regulatory inspections to ensure minimal ...
The Senior Manager, Quality Operations is accountable for driving results in a fast-paced ... Provides direct support and leadership during site regulatory inspections to ensure minimal ...
The Senior Manager, Quality Operations is accountable for driving results in a fast-paced ... Provides direct support and leadership during site regulatory inspections to ensure minimal ...
Job Summary The Senior Manager, Quality Operations is accountable for driving results in a fast ... Provides direct support and leadership during site regulatory inspections to ensure minimal ...
Job Summary The Senior Manager, Quality Operations is accountable for driving results in a fast ... Provides direct support and leadership during site regulatory inspections to ensure minimal ...
The Associate Director, QC Biological identifies operational needs for special projects (new product sub-team, capital projects, etc.)- ensuring site/divisional linkage is achieved. This role ...
The Associate Director, QC Biological identifies operational needs for special projects (new product sub-team, capital projects, etc.)- ensuring site/divisional linkage is achieved. This role ...
Associate Director, QC Biological (Microbiology Focused)
Holly Springs, NC · On-site
$120 - $160/hr
The Associate Director, QC Biological identifies operational needs for special projects (new product sub‑team, capital projects, etc.) ensuring site/divisional linkage is achieved. The Associate ...
Associate Director, QC Biological (Microbiology Focused)
Holly Springs, NC · On-site
$120 - $160/hr
The Associate Director, QC Biological identifies operational needs for special projects (new product sub‑team, capital projects, etc.) ensuring site/divisional linkage is achieved. The Associate ...
Site Quality Director: Sterility & Compliance
Raleigh, NC · On-site
$120 - $150/hr
Indivior PLC is seeking a Director of Quality in Raleigh, NC to oversee the quality site ... Responsibilities include managing quality operations, overseeing compliance inspections, and ...
Site Quality Director: Sterility & Compliance
Raleigh, NC · On-site
$120 - $150/hr
Indivior PLC is seeking a Director of Quality in Raleigh, NC to oversee the quality site ... Responsibilities include managing quality operations, overseeing compliance inspections, and ...
The Associate Director, QC Biological identifies operational needs for special projects (new product sub-team, capital projects, etc.)- ensuring site/divisional linkage is achieved. This role ...
The Associate Director, QC Biological identifies operational needs for special projects (new product sub-team, capital projects, etc.)- ensuring site/divisional linkage is achieved. This role ...
Position Overview The Sr. Director, Quality Control and Analytical Development provides strategic, technical, and operational leadership to the site Quality Control and Analytical Development ...
Quick apply
Position Overview The Sr. Director, Quality Control and Analytical Development provides strategic, technical, and operational leadership to the site Quality Control and Analytical Development ...
Position Overview The Sr. Director, Quality Control and Analytical Development provides strategic, technical, and operational leadership to the site Quality Control and Analytical Development ...
Position Overview The Sr. Director, Quality Control and Analytical Development provides strategic, technical, and operational leadership to the site Quality Control and Analytical Development ...
The Associate Director, QC Biological identifies operational needs for special projects (new product sub-team, capital projects, etc.)- ensuring site/divisional linkage is achieved. This role ...
The Associate Director, QC Biological identifies operational needs for special projects (new product sub-team, capital projects, etc.)- ensuring site/divisional linkage is achieved. This role ...
Sr. Director, Quality Control & Analytical Development
Durham, NC · On-site
$180 - $240/hr
Position Overview The Sr. Director, Quality Control and Analytical Development provides strategic, technical, and operational leadership to the site Quality Control and Analytical Development ...
Sr. Director, Quality Control & Analytical Development
Durham, NC · On-site
$180 - $240/hr
Position Overview The Sr. Director, Quality Control and Analytical Development provides strategic, technical, and operational leadership to the site Quality Control and Analytical Development ...
Director of Laboratory Operations
Cary, NC · On-site
$150 - $190/hr
Role Overview The Director of Laboratory Operations will lead the company's CLIA‑certified ... Quality & Compliance (CLIA / CAP) * Ensure full compliance with CLIA regulations (42 CFR Part 493 ...
Director of Laboratory Operations
Cary, NC · On-site
$150 - $190/hr
Role Overview The Director of Laboratory Operations will lead the company's CLIA‑certified ... Quality & Compliance (CLIA / CAP) * Ensure full compliance with CLIA regulations (42 CFR Part 493 ...
... operations, the company caters to its globally positioned clients by providing dynamic feasible ... Experience and proficiency in using HP test tools including Test Director/Quality Center 9.0 or ...
... operations, the company caters to its globally positioned clients by providing dynamic feasible ... Experience and proficiency in using HP test tools including Test Director/Quality Center 9.0 or ...
... operations, the company caters to its globally positioned clients by providing dynamic feasible ... Experience and proficiency in using HP test tools including Test Director/Quality Center 9.0 or ...
... operations, the company caters to its globally positioned clients by providing dynamic feasible ... Experience and proficiency in using HP test tools including Test Director/Quality Center 9.0 or ...
Lead and coordinate QA initiatives supporting customer accounts, clinical and functional operations, audit and inspection readiness programs, and quality management systems at a regional and/or ...
Lead and coordinate QA initiatives supporting customer accounts, clinical and functional operations, audit and inspection readiness programs, and quality management systems at a regional and/or ...
Lead and coordinate QA initiatives supporting customer accounts, clinical and functional operations, audit and inspection readiness programs, and quality management systems at a regional and/or ...
Lead and coordinate QA initiatives supporting customer accounts, clinical and functional operations, audit and inspection readiness programs, and quality management systems at a regional and/or ...
Lead and coordinate QA initiatives supporting customer accounts, clinical and functional operations, audit and inspection readiness programs, and quality management systems at a regional and/or ...
Lead and coordinate QA initiatives supporting customer accounts, clinical and functional operations, audit and inspection readiness programs, and quality management systems at a regional and/or ...
... proper operation and freedom from defects. This position is responsible for reviewing test cases ... Qualifications Experience and proficiency in using HP test tools including Test Director/Quality ...
... proper operation and freedom from defects. This position is responsible for reviewing test cases ... Qualifications Experience and proficiency in using HP test tools including Test Director/Quality ...
Quality Assurance Specialist II
Morrisville, NC · On-site
Medical
Dental
Vision
Life
Retirement
PTO
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the ... Advise and direct on the interpretation and implementation of regulations, guidelines, company ...
Quality Assurance Specialist II
Morrisville, NC · On-site
Medical
Dental
Vision
Life
Retirement
PTO
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the ... Advise and direct on the interpretation and implementation of regulations, guidelines, company ...
Quality Assurance Specialist II
Morrisville, NC · On-site
Medical
Dental
Vision
Life
Retirement
PTO
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the ... Advise and direct on the interpretation and implementation of regulations, guidelines, company ...
Quality Assurance Specialist II
Morrisville, NC · On-site
Medical
Dental
Vision
Life
Retirement
PTO
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the ... Advise and direct on the interpretation and implementation of regulations, guidelines, company ...
Director Quality Operations information
See Raleigh, NC salary details
$33.1K - $45.9K
4% of jobs
$45.9K - $58.8K
8% of jobs
$58.8K - $71.6K
11% of jobs
$73.7K is the 25th percentile. Wages below this are outliers.
$71.6K - $84.5K
12% of jobs
$84.5K - $97.3K
14% of jobs
The median wage is $99.1K / yr.
$97.3K - $110.2K
12% of jobs
$110.2K - $123.1K
13% of jobs
$126.3K is the 75th percentile. Wages above this are outliers.
$123.1K - $135.9K
9% of jobs
$135.9K - $148.8K
9% of jobs
$148.8K - $161.6K
5% of jobs
$161.6K - $174.5K
3% of jobs
$33.1K
$104.7K
$174.5K
How much do director quality operations jobs pay per year?
What are the key skills and qualifications needed to thrive as a director quality operations, and why are they important?
What are the main challenges a director quality operations typically faces when coordinating cross-functional teams?
What does a director quality operations do?

Full-time
Re-posted 29 days ago
Alcami rating
7.8
Based on 9 frontline employees who took The Breakroom Quiz
Job description
Are you interested in joining our team?
Job Summary
The Senior Manager, Quality Operations is accountable for driving results in a fast-paced environment by continuously challenging the performance of quality standards, systems, and operating procedures. The Senior Manager, Quality Operations provides leadership to the site Quality team who performs quality review and approval of documents, data, protocols, qualifications, change controls, deviations, investigations, complaints, corrective action activities (CAPAs), and quality audits and inspections. This leader develops short and long-range goals, metrics, and objectives, directs the implementation of quality plans, and works with lab management to ensure department goals and objectives are met. The Senior Manager interacts with clients and regulatory agencies regarding quality issues, audits, and inspections.
On-Site Expectations
- 100% on-site position.
- 1st Shift: Monday - Friday, 8:00am - 5:30pm.
Responsibilities
- Ensures compliance with regulatory requirements and Company procedures. Specifically, 21 CFR 210 and 211 and Part 4.
- Collaborates with corporate quality functions to ensure site compliance with the company's Quality Management Systems (QMS).
- Collaborates with site Operations and Technical leadership to ensure timely closure of deviations, non-conformance investigations, corrective actions, and other Quality documents.
- Provides oversight to ensure thorough root-cause analysis for investigations.
- Supports implementation of corrective and preventive actions to eliminate repeat observations.
- Guides, instructs, and coaches members of management in quality and compliance issues.
- Provides direct support and leadership during site regulatory inspections to ensure minimal observations.
- Engages in client audits and client interactions.
- Assists in driving on-time site responses to regulatory and client audit reports and provides direct oversight on commitments and content.
- Develops and implements systems to aid in efficiency and compliance improvements for the site.
- Develops short and long-range goals and objectives for the site quality function.
- Provides Quality support to the Compliance team to maintain the on-time execution of scheduled internal audits and routine supplier management, maintains internal auditing program.
- Ensures controlled documentation is generated, revised, approved, and maintained per corporate and regulatory agency procedures.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring, and performance management.
- Other duties as assigned.
Qualifications
- Bachelor's degree and a minimum of 10+ years of related experience required.
- A minimum of 7 years of supervisory experience is required.
- Prior GMP experience is required; prior CDMO experience preferred.
- Prior experience with GMP warehousing equipment validation, validation protocol review, 21 CFR Part 210 and 211. ISO17025 experience desired.
Knowledge, Skills, and Abilities
- Expert knowledge of pharmaceutical regulatory requirements and cGMP required.
- Knowledge of quality systems and processes, change control, CAPA and data integrity required.
- Knowledge of aseptic processing of commercial or clinical parenteral required for parenteral site(s).
- Knowledge of auditing preferred.
- Excellent skills in leadership, coaching and influencing others, strategic planning, critical thinking and problem solving, root-cause analysis and written communication and presentation skills required.
Travel Expectations
- Up to 10% domestic travel expected.
Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to frequently talk or hear. The employee is frequently required to stand, walk, and sit. The employee is required to occasionally use hands to finger, handle, or feel; climb or balance; stoop, kneel, crouch or crawl; reach with hands and arms; taste or smell. The employee must regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 50 pounds. There is no special vision requirement for this job. The employee may occasionally work in wet or humid conditions, near moving mechanical parts, in high precarious places, near fumes, airborne particles or toxic chemicals.
About Alcami
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Durham, NC, US
Year founded
1979