Quality Assurance Director
5 days ago
Job Overview
This position serves as a strategic quality engagement lead for key customers, promoting proactive quality through risk management and quality improvement activities.
The successful candidate will collaborate with quality counterparts at customers and internal project teams to identify and manage risks, develop action plans for continuous improvement, and ensure adherence to quality issue management requirements.
Responsibilities
- Collaborate with Quality counterparts at customers and with internal project teams to promote, support, and facilitate proactive quality.
- Provide actionable insights from quality and operational data analysis and proactively work with the customer and the account team to develop action plans to drive continuous improvement.
- Analyze trends in quality issue reporting and timeliness to ensure adherence to quality issue management requirements across project teams.
- S supports the management and resolution of significant issues relating to quality.
- In collaboration with Quality Management, ensures projects are inspection ready starting at the design stage.
- Drives inspection readiness activities for the customer, including contributing to mock inspections by/of the customer.
- Contributes to the development of the global risk-based internal audit plan.
- Advises customer Quality counterparts on the strategy for regulatory inspections and collaborates in the preparation for and management of inspections at customer offices and, as necessary, at investigator sites.
- Prepares for and actively participates in relevant Governance/partnership level meetings e.g., Quality Councils/ Joint Operations Committee (JOC) or equivalent meetings with customer Quality counterparts.
- Interfaces with senior management to discuss quality and compliance issues.
- Interfaces with business development and operations to identify business opportunities.
Required Skills and Qualifications
- 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.
Education and Experience
- Demonstrated experience leading and successfully and timely delivering on implementation of cross-functional initiatives and programs with senior executive leadership visibility.
- Demonstrated expertise in implementing a quantitative approach to risk management.
- Minimum 10 years of experience in industry, with at least 3 years of experience in pharmaceutical, biotech, or other regulated industry with a focus on enterprise risk management activities.
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