Sr Dir, QA
Oversee the Quality Assurance program for Response Management; the program for responding with maximum efficiency and effectiveness to Quality Issues, Complaints and significant audit and inspection findings.
- Oversee direction of Quality Assurance Program for response management
- Oversee the timely processing of CAPAs for all audit, inspections, issues and complaints
- Ensure quality assurance organization and operating procedures are optimal to support audit program.
- Perform quality assurance consulting projects, audits, and results analysis within budget and established timelines.
- Chairing of the Critical Events Committee, and Serious Breach Evaluation Committee
- Leading and enhancing the processes for determining event severity, and serious breach reporting
- Host customer audits and regulatory inspections and preparing corrective action plans.
- Participate in or lead teams for special projects as assigned. Teams may be cross functional.
- Oversees the use and enhancements of the Events Driven Analysis (EDA ) system
- Act as Process Owner for audit reporting, quality issue and complaint management, and end to end CAPA management processes
- Monitor and optimize process efficiency and effectiveness through the use of metrics and goal setting
- Liaise with Project Leaders, account and functional management to drive compliance and enhancements to the process and system production of performance and quality metrics
- Oversees root cause analysis conduct and effectiveness checking
- Oversees other core processes and business operations for QA
- Interface with senior management to discuss quality and compliance issues
- Interface with business development and operations to identify business opportunities
- Recommend staff management actions in accordance with organization’s policies and applicable laws. Recommendations include training, coaching, and mentoring employees; planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.
- Performs other duties as needed.
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 the regulatory environment.
- 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 skills.
- Ability to influence and guide others.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
15 years experience in pharmaceutical, technical, quality assurance, or related area, including 6 years of management experience; 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.
Travel is required and may include some international travel.
EEO Minorities/Females/Protected Veterans/Disabled
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