VP Quality Management, Pharma

BD; El Paso (TX); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

BD University

Job summary

BD is seeking a senior Pharma Quality leader to shape and execute QA strategy for pharmaceutical and combination products across El Paso and Sandy facilities. The VP QA will drive QMS, regulatory compliance, and BD Excellence initiatives to enable safe, compliant, and efficient operations.

The role requires extensive experience with FDA interactions, cGMPs, and ISO standards, plus cross-functional leadership spanning manufacturing, R&D, and supply chain.

Qualifications

• Fifteen years of progressive experience in Quality Assurance and Control within regulated manufacturing environments.
• Experience with pharmaceutical and/or combination product QA systems and cGMP requirements.
• Leadership experience in global regulatory inspections and interactions with FDA and other health authorities.
• Experience leading quality strategy for commercial pharma or drug-device combinations.
• Strong capability to manage multiple projects and teams in a matrix organization.

Responsibilities

• Lead and oversee Quality teams for El Paso and Sandy sites; define strategic quality plan.
• Own end-to-end QMS across drug and medical device requirements with ISO 14971 risk framework.
• Drive BD Excellence in quality and lean processes across engineering, manufacturing and distribution.
• Foster a prevention-focused Quality culture and daily quality management practices.
• Coordinate regulatory readiness and remediation efforts for inspections and audits.

Skills

Quality leadership

Regulatory compliance

GMP/cGMP knowledge

Risk management

CAPA oversight

Cross-functional leadership

Education

Bachelor’s degree in technical field

Advanced degree preferred

Job description

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

The Vice President, Quality Pharma (VP, QA) reports solid line to the SVP, Head of Quality and is responsible for shaping and executing Pharma quality strategy in partnership with Integrated Supply Chain (ISC, Business Unit (BU) platforms and BU Quality and Regulatory teams across designated Pharma manufacturing sites.

This role collaborates closely with business and corporate compliance leaders to ensure quality and regulatory strategies and robust Good Manufacturing Practices (GMP) are consistently implemented across the Pharma portfolio within the Surgery and MDS business units, including facilities in El Paso, TX, and Sandy, UT.

The VP QA is accountable for building, leading, and sustaining a high-performing Quality and Compliance organization that meets global regulatory requirements for safety, efficacy, quality, and compliance throughout the design and manufacture of pharmaceutical products. In addition, the VPQ serves as the primary Pharma Quality and Compliance liaison with global regulatory authorities and customers worldwide.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Lead and oversee the Quality teams for El Paso plant and scrub products in the Sandy plant. Develops and maintains a strategic quality plan that defines quality practices, resources, activities, and requirements.

• Provide end-to-end QMS ownership and oversight of an integrated QMS spanning drug and medical device requirements, embedding risk-based decision-making across total product lifecycle with a strong grounding in ISO 14971 risk frameworks applied to combination products.

• Drive the development and continuous improvement of the Quality Management function and its associates to the highest professional and performance standards, including training, accreditation, BD Excellence, and leadership development.

• Drive Quality Excellence through end-to-end BD Excellence processes by developing the organizational capabilities, systems, and governance required to deliver consistent outcomes across engineering, manufacturing, and distribution.

• Lead the deployment of BD Excellence Lean principles, fostering a culture of daily management, continuous improvement, and Lean-driven quality performance.

• Champion a prevention-focused Quality culture by “bringing quality into daily view,” reinforcing accountability, and branding Quality as an enabler of operational excellence.

• Ensure the Quality Management System effectively incorporates existing and emerging regulatory and customer requirements, translating regulatory expectations into practical, sustainable processes that are consistently implemented and maintained.

• Participate in the Management Review Process to ensure executive management reviews the quality system at defined intervals and that improvements or changes are implemented and documented.

• Ensure all Quality Management associates at manufacturing facilities are adequately trained to perform their responsibilities, including regulatory compliance and interactions with FDA, CE, ISO, registrars, notified bodies, and other agencies.

• Harmonize key initiatives across the Pharma platforms and business units using a consistent approach.

• Actively oversee remediation of significant manufacturing and distribution quality performance issues as needed.

• Managing relevant portions of the Quality Management budget to ensure adequate resourcing for quality system responsibilities and business quality plan support.

• Supporting the BD Corrective and Preventive Action (CAPA) process.

• Overseeing monthly quality review activities, acting as the quality interface with manufacturing, R&D, and marketing, and participating in management of the global quality function for products manufactured and distributed within the relevant platforms.

• Ensuring adequate audits of plant facilities, raw material suppliers, finished goods vendors, and contract manufacturers, including remediation activities where needed.

• Investigating and reviewing quality measures and current production performance, including the quality performance of products supplied from plants under responsibility to global markets.

• Monitoring investigations and corrective actions related to complaints associated with products manufactured in plants under responsibility, including Pharma products sold globally.

• Managing and overseeing Pharmaceutical Center of Excellence Quality, and Compliance professionals, a well as plant Quality Management teams within the scope of responsibility.

• Ensuring all products produced in relevant manufacturing plants comply with internal and external quality control standards.

• Monitoring compliance with key quality indicators across the plants under responsibility.

• Promoting best practices and the regular sharing of quality and regulatory information through ongoing quality manager meetings.

Education and Experience:

Education: Bachelor’s degree in a technical field required; Engineering degree strongly preferred. Master’s or Ph.D. degree in a technical field preferred.

Experience:

• Minimum of fifteen years of progressive experience in Quality Assurance and Control within regulated manufacturing environments, including significant experience supporting drug and pharmaceutical products.

• Prior experience should include pharmaceutical and/or combination product quality systems, current Good Manufacturing Practice (cGMP) requirements under 21 CFR Parts 210 and 211, risk management, deviation/CAPA oversight, validation, supplier quality, and inspection readiness.

• Demonstrated leadership experience supporting global regulatory inspections and interactions with agencies such as FDA and other international health authorities is required.

• Experience leading quality strategy for commercial pharmaceutical or drug-led combination product or adjacent area (e.g., injectables, drug delivery systems) manufacturing, including oversight of batch disposition, stability, data integrity, and cross-functional quality governance, is required.

• Experience leading or overseeing remediation efforts in response to FDA Form 483 observations, Warning Letters, and related regulatory enforcement actions is strongly preferred, including development of sustainable remediation plans, root cause analysis, CAPA effectiveness, executive governance, and inspection readiness for reinspection.

Knowledge and Skills:

• Strong command of 21 CFR Part 4 (Combination Products) and how to operationalize drug cGMPs (21 CFR Parts 210/211) and device QMSR and alignment with ISO 13485, including risk management, deviation/CAPA oversight, design controls, process validation, supplier quality and inspection readiness.

• Demonstrated experience with complaint handling, including investigations and MDR and pharmacovigilance reporting globally.

• Knowledge and application of EU MDR + EMA expectations for drug-device combinations, ISO standards (e.g., ISO 13485, ISO 14971), ICH guidelines (Q7, Q9, Q10), and ability to navigate divergent global expectations for medical device, pharmaceutical, and combination products.

• Experienced in project management.

• Strong organizational and motivational skills.

• Capable of managing a range of projects and activities in parallel.

• Ability to partner cross-functionally in a highly matrixed organization, particularly with commercial, supply chain, R&D, medical affairs, and legal teams, and to lead through influence in addition to functional responsibility.

• Strong preparation, planning, and presentation skills for key initiatives.

• Ability to coordinate effectively across regions.

• Ability to communicate effectively in both English and Spanish a plus.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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 health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

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.

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

Optional Skills

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Primary Work Location

USA TX - El Paso - Northwestern Dr.

Additional Locations

Work Shift