- Plan, schedule, conduct, report and close audit activities, as assigned
- Provide Quality Assurance support, guidance and management of Quality Issues, as assigned
- Assist in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to regional and Global QA Management
- Serve as an author for QA Standard Operating Procedures (SOPs), and act as regional QA representative to the global QA SOP taskforce
- Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
- Host customer audits and participate in review of corrective action plans,as assigned
- Recommend systems for audit, write systems audit plans, coordinate scheduling, conduct, reporting and closure of internal system audits
- Serve as the QA Contact for assigned internal/external customers and IQVIA functional areas
- Oversee documentation, reporting, and closure of compliance issues
- Support Quality Management in proposal reviews and reporting QA metrics
- Conduct trend analysis of audit results, provide to internal/external stakeholders as agreed, as assigned
- Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections, as assigned
- Participate in or lead (cross functional) teams for special projects as assigned
- Bachelor's Degree Pref
- 10 years experience Quality Assurance experience in pharmaceutical, technical, or related area including GXP Quality Assurance experience. Equivalent combination of education, training and experience.
- Knowledge of word-processing, spreadsheet, and database applications.
- Strong knowledge of pharmaceutical research and development processes and regulatory environments.
- Considerable knowledge of quality assurance processes and procedures'.
- Strong interpersonal skills and the ability to positively influence and guide others.
- Excellent problem solving, risk analysis and negotiation skills.
- Effective organization, communication, and team orientation and leadership skills.
- Possess applicable experience in conducting audits, writing audit reports and analyzing audits.
- Demonstrated ability to lead and manage multiple responsibilities.
- Identify functional constraints and identify solutions.
- Ability to coordinate timelines with internal customers and external vendors.
- Ability to manage multiple activities and timelines.
- Ability to articulate and define departmental needs and processes.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
-
Quality Assurance Representative
1 week ago
Lilly Durham, United States Full timeWe're looking for people who are determined to make life better for people around the world. · Organization Overview: · Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. This is an exciting ...
-
Quality Assurance Specialist
1 week ago
SBM Management Durham, NC, United States Full timeDescription · Position at SBM Management · SBM Management is looking for a Quality Assurance Specialist to join our team The Quality Assurance Specialist will be responsible for coordinating and managing project tasks in the GMP Program to ensure project delivery within allott ...
-
Quality Assurance Specialist
4 weeks ago
Piper Companies Durham, United StatesPiper Life Sciences is actively seeking a Quality Assurance Specialist (QA) to help join a team whose mission is to help develop products to cure cancer utilizing cutting edge CAR T-cell technology. Getting to see the impact of your work from bench to patient. This person will su ...
-
Quality Assurance Actuary
2 weeks ago
Aspida Financial Services LLC Durham, United StatesJob Description · Job DescriptionDescription:Company Description: · Aspida Holdings Ltd., through its subsidiaries (collectively "Aspida"), is focused on providing retirement and reinsurance solutions, having operations in the U.S. and Bermuda with total assets of $12.1 billion a ...
-
Quality Assurance Specialist
1 week ago
SBM Management Durham, United States Full time· Position at SBM Management · SBM Management is looking for a Quality Assurance Specialist to join our team The Quality Assurance Specialist will be responsible for coordinating and managing project tasks in the GMP Program to ensure project delivery within allotted budget and ...
-
Quality Assurance Specialist
3 weeks ago
SBM Management Durham, NC, United States· Position at SBM Management · SBM Management is looking for a Quality Assurance Specialist to join our team The Quality Assurance Specialist will be responsible for coordinating and managing project tasks in the GMP Program to ensure project delivery within allotted budget and ...
-
Quality Assurance Clerk
3 days ago
The Upper Deck Company Durham, United StatesJob Description · Job DescriptionSUMMARY · Maintaining the quality of products and services. Will be a team player, detail-oriented, and work efficiently in fast-paced work environment. · ESSENTIAL DUTIES AND RESPONSIBILITIES The following statements are intended to describe the ...
-
Quality Assurance Support 3
1 week ago
R.R. Donnelley Durham, United States Full timeCompany Description · RRD is a leading global provider of marketing, packaging, print, and supply chain solutions that elevate engagement across the complete customer journey. The company offers the industry's most trusted portfolio of creative execution and world-wide business ...
-
Quality Assurance Manager, Hybrid
1 week ago
IQVIA Durham, United StatesJob Overview: · Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level. Host onsite (Durham) and remote audits. Provide support to management w ...
-
Quality Assurance Manager, Hybrid
1 week ago
IQVIA Durham, United StatesJob Overview:Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level. Host onsite (Durham) and remote audits. Provide support to management with ...
-
Associate Director, Quality Assurance
2 weeks ago
Biogen Durham, United StatesJob Description · About This Role · This critical position provides QA operational leadership for the RTP Drug Substance Manufacturing site in RTP, specifically in the areas of Small Scale Manufacturing (SSM), Flexible Volume Manufacturing (FVM), and Cell Banking. You will be re ...
-
Associate Director, Quality Assurance
3 weeks ago
Biogen Durham, United StatesJob Description · About This Role · This critical position provides QA operational leadership for the RTP Drug Substance Manufacturing site in RTP, specifically in the areas of Small Scale Manufacturing (SSM), Flexible Volume Manufacturing (FVM), and Cell Banking. You will be res ...
-
Pelthos - Quality Assurance Manager
1 week ago
Ligand Pharmaceuticals Durham, United StatesJob Description · Job DescriptionAs a key member of the Quality Assurance team, the Pelthos Quality Assurance Manager is responsible for the implementation and maintenance of all aspects of the Pelthos Quality Management System in support of internal and outsourced GCP, GLP, and ...
-
Quality Assurance Analyst-Remote
3 weeks ago
Duke University Durham, United StatesDepartment: Duke Health Technology Solutions (DHTS) This position is fully remote, allowing you to collaborate with our team from the following approved states: Arizona California Colorado Connecticut Florida Georgia Hawaii Illinois Maryland Massachusetts Montana New Jersey New Y ...
-
quality assurance analyst-remote
3 weeks ago
Dukehealth Durham, United StatesDepartment: Duke Health Technology Solutions (DHTS) · This position is fully remote, allowing you to collaborate with our team from the following approved states: · Arizona · California · Colorado · Connecticut · Florida · Georgia · Hawaii · Illinois · Maryland · Massa ...
-
Associate Director, Quality Assurance
2 weeks ago
Biogen Durham, United StatesJob Description · About This Role · This critical position provides QA operational leadership for the RTP Drug Substance Manufacturing site in RTP, specifically in the areas of Small Scale Manufacturing (SSM), Flexible Volume Manufacturing (FVM), and Cell Banking. You will be res ...
-
Quality Assurance Analyst-Remote
4 weeks ago
Duke Health Durham, United StatesDepartment: Duke Health Technology Solutions (DHTS) · This position is fully remote, allowing you to collaborate with our team from the following approved states: · Arizona · California · Colorado · Connecticut · Florida · Georgia · Hawaii · Illinois · Maryland · Massachusetts · ...
-
Quality Assurance Analyst-Remote
3 weeks ago
Dukehealth Durham, United StatesDepartment:Duke Health Technology Solutions (DHTS) · This position is fully remote, allowing you to collaborate with our team from the following approved states: · Arizona · California · Colorado · Connecticut · Florida · Georgia · Hawaii · Illinois · Maryland · Massac ...
-
Quality Assurance Engineer II, Device
1 week ago
United Therapeutics Corporation Durham, United States Full timeCalifornia, US residentsclick here. · The job details are as follows: · What We Do · We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun ...
-
Senior Quality Assurance Specialist
1 week ago
HUMACYTE GLOBAL INC Durham, United StatesJob Description · Job DescriptionSenior Quality Assurance Specialist · Position Profile · Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on imp ...
Associate Director, Quality Assurance - Durham, United States - IQVIA
Description
Job Overview:
Provide insight which is exercisable across the large part of the organization or by managing a team of managers by influencing outcomes.
Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level.
Provide insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives.
Manage the quality assurance oversight of projects, assignments, training and staff.Essential Functions:
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.
Learn more at We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.
The potential base pay range for this role, when annualized, is $106, $197, The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).
Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
SummaryLocation:
San Francisco, CA, United States of America; Durham, North Carolina, United States of AmericaType: Full time
