Quality Director

RXinsider LTD.; Maryland; On-site; USD 163,000 - 293,300; Full time

Job summary

Waters Corporation is seeking a senior quality/regulatory leader to shape and oversee the quality function in alignment with corporate strategy. The role requires coordinating with top management, setting budgets and performance standards, and ensuring compliance with FDA and ISO requirements.

You will lead cross-functional teams, drive strategic initiatives, and interact with executive stakeholders to ensure high-quality, compliant operations across the organization.

Qualifications

• Proven ability to write clear, precise communications for diverse audiences.
• Ability to lead a management team and manage subordinate managers.
• Knowledge of FDA 21 CFR 820 and ISO 13485:2003 requirements.

Responsibilities

• Establishes strategy and direction; ensures effective implementation for the quality function.
• Interacts with executive-level management; negotiates critical matters.
• Manages budgets, schedules and performance requirements.
• Leads leadership teams and advances leadership bench strength.

Skills

Leadership ability

Written communications

Budget management

Executive stakeholder negotiation

Cross-functional collaboration

Strategic thinking

Regulatory knowledge

Education

Bachelor’s degree in science/engineering

Job description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We Are The People Who Give Possibilities Purpose

Job Description

• Decisions have an extended impact on work processes and outcomes. Erroneous decisions result in critical delays and modification to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business performance
• Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
• Implements strategic policies when selecting methods and evaluation criteria for obtaining results.
• Establishes and assures adherence to budgets, schedules, work plans and performance requirements. This position is accountable for responsibilities with high complexity. Has in-depth understanding of quality and regulatory principles.
• Establishes strategy and direction. Ensures effective implementation for the assigned quality function in alignment with strategic plans established with top management and executive leadership. Contributes to business strategies and plans.
• Interprets company-wide policies and procedures. Develops budgets, schedules and performance standards.
• Interact both internally and externally with executive-level management, requiring negotiation of critical matters.
• Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
• Often serves on Leadership Teams such as ESC (Executive Steering Committee), Plant LT (Leadership Team), Extended Quality LT
• Establishes operational objectives and work plans; delegates assignments to associates.
• Manages subordinate managers and/or experienced specialist employees who exercise significant latitude and independence
• Advances the Leadership Bench strength of the company.

Qualifications

• Ability and skill to effectively manage multiple tasks and drive execution of organizational objectives and strategies
• Ability and skill to lead a management team in managing subordinates and executing organizational objectives and/or strategies
• Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
• Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and senior management/executive level
• Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems
• Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution
• Sound workable knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) I ISO 13485:2003
• Ability to identify and develop medium and high potential associates
• Ability to manage budgets, work schedules and performance requirements

Minimum Education And Experience

Typically requires a minimum of a bachelor’s degree in science, engineering or other relevant discipline, with a minimum of ten plus years relevant supervision experience. Often viewed as a thought leader in a specific area.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

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.

Required Skills

Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Work Shift

At BD, reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You".

Salary Range Information

$163,000.00 - $293,300.00 USD Annual