Vacancy caducado!
Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.PURPOSEOversee & coordinate QA program for assigned customer projects at a regional and/or global level. Provide support in the promotion and assessment of compliance with regulations, guidelines, and operating procedures among sites within the region.RESPONSIBILITIES
Plan, schedule, conduct, report and close audit activities
Assist in establishment of QA & control policy, provide consultation & recommendations to regional and Global QA Management
Serve as an author for QA SOPs, may 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, participate in review of corrective action plans.
Recommend systems for audit, write systems audit plans, coordinate scheduling, conduct, reporting and closure of internal system audits.
Serve as Global QA Contact for assigned customers and Quintiles 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 QA mgmt with initial root cause analysis
Ensure proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections.
Participate in or lead (cross functional) teams for special projects as assigned.
All responsibilities are essential job functions unless noted as nonessential (N).REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Regulatory (and associated Standards, Guidelines, and Industry Best Practices) interpretation, implementation, and application of FDA Part 11, GLP, GMP, GCP, CLIA, QSR, ERES; Annex 11; ISPE GAMP 5, ISO 9001, 15189, ICH E6
Experience with equipment qualification and validation (IQ, OQ, PQ)
Experience with software validation principles (V model) (SDLC and Software Validation Life Cycle)
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.
Excellent problem solving, risk analysis and negotiation skills.
Effective organization, communication, and team orientation and leadership skills.
Ability to influence and guide others
Ability to manage costs effectively through appropriate resource allocation
Management experience in Quality Assurance
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s/primary degree
10 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience; 3 years of management experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech.
Travel may be required
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/DisabledIQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [email protected] to arrange for such an accommodation.At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.
Vacancy caducado!