IQVIA · 5 hours ago
Associate Director, Quality Assurance
Durham, NC
Full-time
Remote
Director/Executive
$106K/yr - $198K/yr
10+ years exp
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Responsibilities
Host customer audits and participate in review of corrective action plans, as assigned.
Manage a team of up to 5 direct reports
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
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
Promote the concept of quality, the principles of quality management and devise and implement quality improvements
Qualification
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Required
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.
Preferred
Bachelor's Degree
Line management experience preferred
Benefits
Incentive plans
Bonuses
Health and welfare and/or other benefits
Company
IQVIA
IQVIA provides analytics, compliance, and management solutions to the life sciences industry.
10,001+ employees
H1B Sponsorship
IQVIA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (218)
2022 (199)
2021 (286)
2020 (197)
Funding
Current Stage
Public CompanyTotal Funding
$1.5B2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
2019-08-08Post Ipo Equity· undefined
Leadership Team
Chris Colapietro
Vice President, Customer Engagement
Christina Bodurow
Vice President, Global Regulatory Affairs
Recent News
2024-10-31
The Pharma Letter
2024-05-29
2024-05-05
Company data provided by crunchbase
