Associate Director, QA

Associate Director of Quality Assurance

The Associate Director of Quality Assurance reports to the Sr. Director of Quality, BD Life Science (BDB) Business Unit. This position is responsible for the Quality Assurance and provides direct management to technical and managerial staff often at multiple locations. The role significantly influences the definition of the global strategy and determines the tactics required to achieve objectives. Through outstanding communication; effective problem solving and active management of ambiguous situations; the Associate Director ensures product safety, product quality and compliance with all relevant global regulations and customer expectations. This position will also support the planning and implementation of Reagent Quality strategy for BDB aligned with corporate key driver goals. Success is measured in terms of the frequency and scale of product quality and organizational issues as well as business process effectiveness. Through internal and external stakeholder engagement; and people development; the Associate Director produces durable and industry leading results supporting key business drivers.

Engage with (or may lead) global quality networks as well as the business unit and associates toward the effective promotion and alignment of organizational goals to the company's mission and vision. Ensure the functional quality organization is designed and resourced to fulfill its obligations and to align with applicable regulations and procedures.

Primary Responsibilities:

• Manage customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards.
• Support Corporate initiatives, Key Driver Goals (KDGs) and Biosciences objectives to improve reagent plant product quality. Ensure programs are led, supervised, and delivered according to corporate and Biosciences timeline.
• Continuously evaluate progress toward objectives adapting them to meet customer and business needs. Pursue and actively manage key stakeholder relationships that support the broader strategy that are impacted by plant/business/function objectives. Significantly contribute to development of local and/or global strategies.
• Ensure the functional quality organization is designed and resourced to fulfill its obligations and to align with applicable regulations and procedures. Mentor and develop personnel, including dedicated succession planning and contingency management.
• Support new product development for operational aspects and ensure adequate design transfer from R&D.
• Serves on Leadership Teams such as Platform, ESC (Executive Steering Committee), Plant LT (Leadership Team), Extended Quality LT.
• Effectively navigate and lead through the challenges of change and establish global stakeholder engagement focused on effective solution solutions.
• Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors. Perceived as leader with vision possessing subject matter expert knowledge of global regulations. May have P&L accountability.
• Act as management representative for notified bodies and liaison with regulatory authorities and customers, by hosting and managing related audits and ensuring effective resolution.
• Build an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies.
• Perform all other duties and supports projects as assigned.

Minimum Requirement:

• A minimum of a bachelor's degree in science, engineering, or other relevant discipline with a minimum of eight (8) years relevant experience in the pharmaceutical and/or medical device industries, with three (3) years supervisory experience.
• Experience with GMP/ISO compliance and documentation, and FDA Regulations.
• Knowledge of manufacturing systems, medical products and related materials, quality testing and quality auditing.
• Six Sigma or Lean certification desired.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

USA CA - San Diego (BDB)

Salary Range Information

$169,800.00 - $280,300.00 USD Annual