QUALITY DIRECTOR

Job Summary :

The Quality Director role is responsible for leading all aspects of a global quality function including Quality Control & Assurance.

Responsibilities :

Role Specific Responsibilities :

• Provides leadership for the company-wide quality function, ensuring proper programs and processes developed and in place to ensure compliance with Aurorium Global Quality Standards, relevant regulatory authority expectations, and internal and external customer requirements
• Champions a customer-centric quality organization that focuses on delivering high quality products as a differentiator and is responsive to addressing both internal and external end customer needs and issues.
• Assumes responsibility for management and supervision of site Quality Managers who are responsible for testing, release, and monitoring of operational and product quality.

Ensures all site Quality labs exceed safety and data integrity standards.

• Initiates and leads improvements across the entire lifecycle of products, including, raw material qualification, change control, deviations, batch release, stability, complaint management, and performance data review
• Partners closely with other functions to ensure all decisions and actions are determined through the application of good science, risk management, and the most current regulatory requirements
• Partner with R&D and business teams as part of the new production development process to enable launch of new growth products
• Plans annual and multi-year goals for Quality Assurance and Quality Control company-wide; evaluates the quality department to ensure that all required knowledge and skills are available to meet those objectives
• Creates, modifies and implements Quality Plans to drive continuous improvement initiatives
• Provides oversight of investigations to resolve issues that may impact on the quality of manufactured product and ensure long term preventative solutions are implemented
• Ensures compliance of all activities performed by 3rd Parties or suppliers (e.g., Audit adherence; Quality Agreements), as required by applicable internal standards and regulatory authorities
• Develops talent to sustain local and market network competitiveness, identifies individuals with leadership potential, provides mentoring and enrichment opportunities consistent with succession planning
• Communicates periodic updates on the quality compliance status of the organization
• Management of departmental budget, cascaded into quality department for accountability
• Able to travel on a global basis up to 30% of time
• Performs any other duties or serve in such other capacity as may be determined by company management

Compliance :

• Complies with company Health, Safety and Environmental policies, procedures, and arrangements
• Reports all Health, Safety and Environmental accidents, incidents and near misses promptly
• Acts in a safe and responsible manner at all times

Problem Solving and Innovation :

• Active participation in continuous improvement activities
• Participates in problem-solving
• Takes responsibility and ownership for own learning and development in the spirit of continuous improvement of both self and the business
• Assists in the training, mentoring, and assessment of other team members
• Exercises autonomy and judgement subject to overall direction or guidance

Qualifications / Desired Skills :

Education and Qualifications :

M.S. or Ph.D. in Analytical Chemistry (or equivalent)

Experience :

• A minimum of 15 years of experience leading Quality teams in the chemical industry.
• Demonstrated experience working in cGMP (Current Good Manufacturing Practice) and ISO (International Standards Organization) environments
• Demonstrated experience improving quality process across a global enterprise
• Demonstrated experience building and managing global teams

Knowledge, Skills, and Abilities :

• Intellectual curiosity and passion for learning new chemistry, processes and products.
• Strong organizational skills and attention to detail
• Excellent verbal and written communication skills with ability to communicate effectively across all levels of the organization
• Ability to lead and work within a multi-functional, matrixed, global organizational structure and exhibits robust interpersonal and influencing skills across different cultures
• Strong people leadership and ability to mentor and develop individual contributors and managers
• Critical thinking skills and analytical abilities which allow assessments of situations and opportunities
• Expertise in leading root cause investigation and generating corrective action plans.
• Proven change agent with high personal accountability
• Proficient in Microsoft office applications such as Excel, Word, Power Point, Outlook, etc.
• Adaptability for working with cloud-based document and project management software
• Embodies the core values of Aurorium : credible : keeps their word and honors their commitments, acts with integrity, and holds themselves accountable to their decisions and actions outcome-oriented : adheres to an unparalleled standard of excellence in everything they do, to deliver results with real impact driven : passionate about delivering authentic, world-class experiences that engage customers and inspire greatness empowered accountability : empowered to achieve common goals and accountable for delivering performances and results that exceed standards
30+ days ago