Summary As Director, Global Sterility Assurance Team Lead you will: • Lead a team (4-6 direct ... QA operations, QA compliance lead, QC/AS&T lead) * Own, Monitor and act as Primary contact for the ...
Summary As Director, Global Sterility Assurance Team Lead you will: • Lead a team (4-6 direct ... QA operations, QA compliance lead, QC/AS&T lead) * Own, Monitor and act as Primary contact for the ...
Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kin...
Summary of Responsibilities Provides executive leadership for Quality Assurance (QA) and Regulatory Compliance within the Clinical Pharmacology Services (CPS) business unit, ensuring a robust, risk ...
Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kin...
Summary of Responsibilities Provides executive leadership for Quality Assurance (QA) and Regulatory Compliance within the Clinical Pharmacology Services (CPS) business unit, ensuring a robust, risk ...
Quality Assurance (QA) Engineer / Senior QA Specialist (TEST) Experience Required: 7-10 Years Location: Raleigh, NC Visa: US Citizen / Green Card Mode of Work: In-office Duration: 10 to 12 months ...
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Quality Assurance (QA) Engineer / Senior QA Specialist (TEST) Experience Required: 7-10 Years Location: Raleigh, NC Visa: US Citizen / Green Card Mode of Work: In-office Duration: 10 to 12 months ...
Quality Assurance Inspector
Clayton, NC · On-site
Primary Responsibilities: - Approves incoming plasma shipment documentation and raw materials by confirming specifications, rejects and returns unacceptable materials as directed by QA Supervisor ...
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Quality Assurance Inspector
Clayton, NC · On-site
Primary Responsibilities: - Approves incoming plasma shipment documentation and raw materials by confirming specifications, rejects and returns unacceptable materials as directed by QA Supervisor ...
Quality Assurance Inspector
Clayton, NC · On-site
Primary Responsibilities: - Approves incoming plasma shipment documentation and raw materials by confirming specifications, rejects and returns unacceptable materials as directed by QA Supervisor ...
Quality Assurance Inspector
Clayton, NC · On-site
Primary Responsibilities: - Approves incoming plasma shipment documentation and raw materials by confirming specifications, rejects and returns unacceptable materials as directed by QA Supervisor ...
About the Role EnrollHere is seeking a highly driven Head of Product & Quality to lead product execution, customer engagement, quality assurance, and delivery across our platform. This is a hands-on ...
About the Role EnrollHere is seeking a highly driven Head of Product & Quality to lead product execution, customer engagement, quality assurance, and delivery across our platform. This is a hands-on ...
The Senior QA Engineer will also work outside their assigned product development teams on quality initiatives as directed by the QA Manager. The Senior QA Engineers responsibilities include, but are ...
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The Senior QA Engineer will also work outside their assigned product development teams on quality initiatives as directed by the QA Manager. The Senior QA Engineers responsibilities include, but are ...
Senior QA Engineer
Cary, NC · On-site
$40/hr
The Senior QA Engineer will also work outside their assigned product development teams on quality initiatives as directed by the QA Manager. The Senior QA Engineers responsibilities include, but are ...
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Senior QA Engineer
Cary, NC · On-site
$40/hr
The Senior QA Engineer will also work outside their assigned product development teams on quality initiatives as directed by the QA Manager. The Senior QA Engineers responsibilities include, but are ...
Quality Assurance Associate
Henderson, NC · On-site
Quality Assurance Specialist • Preparing and implementing quality assurance policies and procedures • Performing routine inspections and quality tests • Identifying and resolving workflow and ...
Quality Assurance Associate
Henderson, NC · On-site
Quality Assurance Specialist • Preparing and implementing quality assurance policies and procedures • Performing routine inspections and quality tests • Identifying and resolving workflow and ...
Quality Assurance Associate
Henderson, NC · On-site
Quality Assurance Specialist • Preparing and implementing quality assurance policies and procedures • Performing routine inspections and quality tests • Identifying and resolving workflow and ...
Quality Assurance Associate
Henderson, NC · On-site
Quality Assurance Specialist • Preparing and implementing quality assurance policies and procedures • Performing routine inspections and quality tests • Identifying and resolving workflow and ...
About the Role EnrollHere is seeking a highly driven Head of Product & Quality to lead product execution, customer engagement, quality assurance, and delivery across our platform. This is a hands-on ...
About the Role EnrollHere is seeking a highly driven Head of Product & Quality to lead product execution, customer engagement, quality assurance, and delivery across our platform. This is a hands-on ...
About the Role EnrollHere is seeking a highly driven Head of Product & Quality to lead product execution, customer engagement, quality assurance, and delivery across our platform. This is a hands-on ...
Quick apply
About the Role EnrollHere is seeking a highly driven Head of Product & Quality to lead product execution, customer engagement, quality assurance, and delivery across our platform. This is a hands-on ...
Quality Assurance Inspector
$21 - $23/hr
DIRECT Hire Only. No Recruiters. No Phone Calls * * * Job Title : Quality Assurance Inspector Job Type: Full-time Location: Oxford, NC. Company Overview: H3 Manufacturing is a leading integrated ...
Quality Assurance Inspector
$21 - $23/hr
DIRECT Hire Only. No Recruiters. No Phone Calls * * * Job Title : Quality Assurance Inspector Job Type: Full-time Location: Oxford, NC. Company Overview: H3 Manufacturing is a leading integrated ...
Quality Assurance Inspector
Oxford, NC · On-site
$21 - $23/hr
DIRECT Hire Only. No Recruiters. No Phone Calls * * * Job Title : Quality Assurance Inspector Job Type: Full-time Location: Oxford, NC. Company Overview: H3 Manufacturing is a leading integrated ...
Quality Assurance Inspector
Oxford, NC · On-site
$21 - $23/hr
DIRECT Hire Only. No Recruiters. No Phone Calls * * * Job Title : Quality Assurance Inspector Job Type: Full-time Location: Oxford, NC. Company Overview: H3 Manufacturing is a leading integrated ...
Vice President, Quality
Clayton, NC · On-site
$150 - $200/hr
Direct the establishment of Quality policies, systems, procedures and specifications for raw ... assurance/control and manufacturing practices. * Actively participate in site and Grifols ...
Vice President, Quality
Clayton, NC · On-site
$150 - $200/hr
Direct the establishment of Quality policies, systems, procedures and specifications for raw ... assurance/control and manufacturing practices. * Actively participate in site and Grifols ...
QA Manager - Laboratories
$75K - $105K/yr
The QA Manager also plans and leads initiatives to drive continuous improvement of laboratory ... Partnering with the Laboratory Director and Operations Managers to identify inefficiencies and ...
New
QA Manager - Laboratories
$75K - $105K/yr
The QA Manager also plans and leads initiatives to drive continuous improvement of laboratory ... Partnering with the Laboratory Director and Operations Managers to identify inefficiencies and ...
New
Timberlake, NC (onsite) Schedule: Full-time | Exempt About the Role Voltage is seeking a hands-on Quality Assurance Supervisor to lead the daily activities of the Quality team in a high-volume wire ...
Timberlake, NC (onsite) Schedule: Full-time | Exempt About the Role Voltage is seeking a hands-on Quality Assurance Supervisor to lead the daily activities of the Quality team in a high-volume wire ...
QA Specialist (Hybrid)
Raleigh, NC · On-site
$66K - $86K/yr
The QA Specialist, External Manufacturing Quality Operations (EMQO) supports Quality Assurance ... directed, goal-oriented, and quality conscious. • Demonstrates a strong learning mindset and ...
QA Specialist (Hybrid)
Raleigh, NC · On-site
$66K - $86K/yr
The QA Specialist, External Manufacturing Quality Operations (EMQO) supports Quality Assurance ... directed, goal-oriented, and quality conscious. • Demonstrates a strong learning mindset and ...
QA Specialist (Hybrid)
Raleigh, NC · Hybrid
$66K - $86K/yr
The QA Specialist, External Manufacturing Quality Operations (EMQO) supports Quality Assurance ... Must be self-directed, goal-oriented, and quality conscious. Demonstrates a strong learning mindset ...
QA Specialist (Hybrid)
Raleigh, NC · Hybrid
$66K - $86K/yr
The QA Specialist, External Manufacturing Quality Operations (EMQO) supports Quality Assurance ... Must be self-directed, goal-oriented, and quality conscious. Demonstrates a strong learning mindset ...
Timberlake, NC (onsite) Schedule: Full-time | Exempt About the Role Voltage is seeking a hands-on Quality Assurance Supervisor to lead the daily activities of the Quality team in a high-volume wire ...
Timberlake, NC (onsite) Schedule: Full-time | Exempt About the Role Voltage is seeking a hands-on Quality Assurance Supervisor to lead the daily activities of the Quality team in a high-volume wire ...
Qa Director information
See Raleigh, NC salary details
$54.9K - $70K
3% of jobs
$70K - $85.1K
9% of jobs
$99.4K is the 25th percentile. Wages below this are outliers.
$85.1K - $100.3K
14% of jobs
$100.3K - $115.4K
14% of jobs
$115.4K - $130.5K
10% of jobs
The median wage is $131.1K / yr.
$130.5K - $145.6K
14% of jobs
$158.1K is the 75th percentile. Wages above this are outliers.
$145.6K - $160.7K
14% of jobs
$160.7K - $175.8K
11% of jobs
$175.8K - $190.9K
6% of jobs
$190.9K - $206K
3% of jobs
$206K - $221.1K
2% of jobs
$54.9K
$136.2K
$221.1K
How much do qa director jobs pay per year?
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Full-time
Medical, Retirement, PTO
Re-posted 5 days ago
Novartis rating
7.5
Based on 17 frontline employees who took The Breakroom Quiz
64th of 86 rated pharmaceutical
Job description
Job Description Summary
As Director, Global Sterility Assurance Team Lead you will:• Lead a team (4-6 direct reports, 20-30 indirect) of Key functional Expert for Aseptic processing within the Novartis manufacturing network (includes Large Molecules and Advance therapies and third parties producing for Novartis).
• Ensures and verifies that all actions related to FDA and other health authority inspections are understood and implemented by the sites in the platform, avoiding re-occurrence of 483’s and Warning Letters.
• Assure that key projects are implemented in the manufacturing sites as per committed plan to FDA and other health authorities
• Ensure implementation of changes to support GMP updates (i.e. Annex 1) within all the sites in scope in order to assure ongoing compliance for the upcoming years. In this regard supports the gap assessment process and respective remediation and action tracking.
• Liaise with TechOps to ensure implementation, follow up and completeness of all related Quality/ Compliance programs, documentation and Quality reporting of Aseptic related projects / metrics.
• Ensure adequate Health Authority Inspection preparation of the Sites in scope and successful inspection outcomes. Interactions with sites mainly require interpretation of complex information and persuasion both internally with other areas of the business and the site leadership team and externally.
Job Description
Major Accountabilities:
- Overall team leader that has the responsibility of 4-6 individual contributors hosted in US, Spain and Austria, plus 20-30 indirect reports located within the manufacturing sites performing sterile operations.
- Lead cross site/platform and network projects and harmonization initiatives as assigned
- Provide expert advice and appropriate technical support to ensure site readiness for Health Authority and GGA inspections by supporting sites in their preparation, up to and including hands on preparation of materials (i.e. storyboards for complex cases, etc.)
- Primary Responsible for optimization of aseptic processes (as e.g. cleaning and disinfection programs, microbiological monitoring and sterilization techniques) between sites and platforms within the Novartis manufacturing network
- Support escalations for specific topics (i.e. Microbial contaminations, sterility issues, etc.) with the manufacturing sites if needed, and in collaboration with the other members of the platform (i.e. QA operations, QA compliance lead, QC/AS&T lead)
- Own, Monitor and act as Primary contact for the sterility assurance from the sites and define improvement plans as appropriate.
- Build fit for purpose aseptic governance and training program in collaboration with engineering and MS&T to support sites in development, training and understanding of aseptic topics
- Provides input for the selection, training, people development and performance evaluation, development planning and participating in recruiting process of the Aseptic experts within the manufacturing sites / global functions.
Obligatory requirements:
- Education: Graduate in Chemistry, Pharmacy, Microbiology or another related science; desirable: Ph.D. in science or related discipline
- 12 - 15 years experience in management and leadership roles in the pharmaceutical industry, preferably in a FDA-regulated environment and in QA Operations & Compliance of a strategic Site or a global role. Pharma production experience indispensable. Quality Assurance / cGMP regulations in USA, EU (Self Inspections, Auditing of 3rd parties, Complaint/Deviation Handling, GMP-Training, SOP-Systems).
- Deep understanding of microbiology and aseptic processes
- Solid People Management / Communication skills (To explain difficult business processes and related GMP-requirements to a community of very diversely oriented and educated people from a multitude of different units.
- Excellent Project Management skills, especially with crossfunctional projects.
- Fluent English written and spoken.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
You will receive: Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 27 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Skills Desired