Director of Quality

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The Quality Operations Director is responsible for leading the Quality Assurance and Quality Control teams, driving Quality vision, plans to execute at the local site and driving the definition of site quality objectives, metrics and reporting and operating mechanisms.

Key responsibilities/essential functions include:

• Leads the Quality Management System for the site.
• As a member of the Site Leadership, engages with peers to drive set site strategic goals and objectives.
• Leading and driving specific product compliance across site -owns the Corrective and Preventive Actions process and training, employee training and development, internal audit programs, and the new product introduction (NPI) milestone approval process
• Accountable for each of the metrics for the business (i.e. complaint investigation, internal audit score, product quality, employee engagement, etc.) and management review process
• Influencing hiring decisions, product compliance process development, and new product introduction (NPI)
• Translates the Quality vision into goals, objectives strategies and measures for the site
• Creates transparency, visibility and monitoring of common quality metrics in the QA organization.
• Responsible for the leadership of employees as well as coaching and development QA professionals at all levels of the organization via matrix of direct and/or dotted line responsibilities.

• Assure site and business is properly prepared for external and internal compliance inspections by having results from there inspections be non-systemic and without warning letters
• Understanding customer needs, marketplace dynamics, industry trends & the competitive landscape in the industry & considers the external impact of business activities & decisions on the external environment
• Assure specific site and business goals are established and met for compliance, training, CAPA, complaints and production process controls.

Desired Characteristics

• Experience in QA in Pharmaceutical industry
• Demonstrated experience with applying classic Quality tools Experience interfacing global regulatory agencies & ability to interface with governmental regulators
• Ability to comprehend & communicate/translate key regulatory body requirements/expectations
• Demonstrated ability to lead teams across poles/cultures/sites
• Ability to detect trends/shifts in requirements & align/shift internal organization priorities & actions accordingly
• Influencing/advocacy-able to determine a position & argue it effectively within the business context

Required Qualifications:

Bachelor's degree and 14 years business experience. Minimum of 10 years of operational/business experience Strong project management and prioritization skills, ability to effectively manage multiple tasks and priorities Superior ability to lead change with global &, cross-functional teams Proven ability to drive operational excellence Knowledge of and exposure to manufacturing or engineering processes