Principal Clinical Quality Specialist

Job Description Summary

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 Principal Clinical Quality Specialist is responsible for supporting the Global Clinical Research organization. This role will focus on ensuring that regulatory compliance, GCP, subject safety, and data integrity are maintained while also encouraging innovative research solutions. Partners with clinical study teams in a way that fosters open and trusting dialogues.

KEY RESPONSIBILITIES:

• Experienced clinical quality and compliance professional with a focus on supporting, guiding, and teaching clinical study teams at every stage in the clinical study lifecycle (i.e., planning, execution, closeout)

• Drives partnership with project, program, and functional managers by acting as a direct link between the Clinical Research Quality organization and clinical study teams

• Proactively identify compliance issues and lead the associated teams to an effective resolution

• Serve as a strategic partner with stakeholders in relation to ongoing risk assessment of clinical trial activity

• Identify and escalate significant compliance issues to the Senior Manager of Clinical Quality and Compliance and other relevant leadership, including the assessment of serious breaches; ensure the completion of appropriate remediation activities

• Accountable to develop and drive change management in assigned areas of focus to ensure continuous process improvement

• Lead clinical study teams throughout the audit and CAPA response processes including strong root cause analysis and effective corrective/preventive actions

• Attend functional study team meetings and actively address ad hoc business unit needs and issues

• Review key study documents (e.g., Clinical Investigation Plans, Investigator’s Brochure, informed consents, study-specific risk management documentation) to ensure compliance with regulations, standards, and internal processes

• Serve as Clinical Quality representative in company-wide clinical research initiatives

• Support Vendor Management in vendor qualification activities, as needed, and in the resolution of vendor compliance issues and CAPAs

• Support regulatory inspections (e.g., BIMO) at clinical sites and sponsor, including inspection prep activities

• Share quality topics and lessons learned to the organization

QUALIFICATIONS:

• Bachelor’s degree required

• Minimum 7 years’ experience in clinical research required

• Prior work experience in a clinical quality, clinical compliance, or clinical auditing role

• Prior experience in study management or monitoring in investigational medical device or diagnostic trials preferred

• Advanced knowledge of and experience with MedTech regulations and standards (e.g., 21 CFR 812, 50, 54, 56, ISO 14155, ISO 20916, ISO 13485, ISO 14971, EU MDR/IVDR, China FDA, JGCP, ICH E6)

• Knowledge and understanding of clinical development programs and clinical trial processes as well as quality management systems and quality control tools

• Clinical research certification preferred

PERSONAL CHARACTERISTICS:

• Demonstrated leadership competencies

• Servant leader with strong mentoring capabilities

• Ability to work autonomously and manage through ambiguity

• Able to be accountable for managing multiple program objectives concurrently

• Effective communication skills both verbal and written

• Establishes rapport and collaborates with other (internal and external) partners; builds constructive and effective relationships

• High attention to detail and accuracy

• Strong interpersonal skills with the ability to work well with teams

• Knowledgeable in effective training techniques that engage learners

• Multi-disciplinary knowledge across functional areas

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.

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.  

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/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status. 

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At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

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