Quality Assurance Manager
Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise. The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities.
Provide support to mgmt in the promotion and assessment of compliance with regulations, guidelines, and operating procedures. Manage QA oversight of projects, assignments, and training. Conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures.
- Plan, schedule, conduct, report and close audit activities in any of the countries involved with Quintiles contracts. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions.
- Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
- Provide consultation to customers, functional leads and monitors in interpretation of audit observations and formulation of corrective action plans.
- Prepare, review and approve corrective action plans
- Present educational programs and provide guidance to operational staff on compliance procedures.
- Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
- Host customer audits
- Host mock regulatory inspections and regulatory facility inspections
- Provide training for new Quality Assurance staff.
- Serve as author of Quality Assurance SOPs as assigned.
- Advise Quality Assurance management on system audit needs.
- Act as regional or Global QA Coordinator for assigned customers projects
- Oversee documentation, reporting, and closure of compliance issues
- Lead Projects.
- Train new auditors and staff as required.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Knowledge of word-processing, spreadsheet, and database applications.
- Extensive 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.
- Exceptional training capabilities.
- Effective organization, communication, team orientation, and leadership skills.
- Ability to work independently with initiative.
- Ability to manage multiple projects.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s/primary degree
- 7 years Quality Assurance experience in pharmaceutical, technical, or related area; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience
- 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.
- Occasional travel.
EEO Minorities/Females/Protected Veterans/Disabled
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