Job ID R-443832 Date posted 08/14/2022 Apply

Manager, Clinical Quality and Compliance (Remote USA)

Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

JOB SUMMARY:

The Manager, Clinical Quality and Compliance, is a clinical research role responsible for supporting the Clinical Quality and Compliance (CQC) team within the Global Clinical Affairs (GCA) organization. This role will manage a team focused on ensuring that regulatory compliance, GCP, subject safety, and data integrity are maintained across clinical trials while also encouraging innovative research solutions.

KEY RESPONSIBILITIES:

Under the direct supervision of the Director, Clinical Quality and Compliance, the Manager, Clinical Quality and Compliance, role will include:

  • Accountability for direct functional line management and performance of a team of Clinical Quality and Compliance Specialists within Global Clinical Affairs (GCA), including resource allocation, adherence to project timelines, and compliance with all governing documents (e.g., SOPs) and regulatory requirements.

  • Support and develop the Clinical Quality and Compliance (CQC) team in its mission to champion the strategic application of regulations, standards, and internal processes at every stage of the clinical study lifecycle (i.e., planning, execution, closeout). This mission is achieved via Clinical Quality and Compliance Specialists working closely with assigned study teams to proactively influence clinical study activities and, when necessary, to guide study teams in bringing studies and sites back into compliance.

  • Maintain oversight of all CAPA and audit response processes related to clinical research.

  • Lead continuous process improvement initiatives within and outside the Quality Management System.

  • Develop and implement methods for best practice sharing across the Global Clinical Affairs organization.

  • Proactively identify and escalate significant compliance issues to the Director of Clinical Quality and Compliance and other relevant leadership, including the assessment of serious breaches; ensure the completion of appropriate remediation activities.

  • Actively manage the performance development and review process for all direct reports.  Provide feedback on an ongoing basis to all accountable staff members.  Identify growth and succession planning opportunities for direct reports.

  • Develop and/or oversee the interviewing, hiring, training, and onboarding of CQC staff, as well as assess ongoing training and development needs.

  • Review/approve expenses and ensure compliance with company travel policies.

  • Lead regular staff meetings with CQC team members.

QUALIFICATIONS:

  • Bachelor’s Degree required, preferably in the life sciences, advanced degree preferred

  • Minimum 7 years of experience in clinical research required

  • Minimum 4 years of experience in a clinical quality, clinical compliance, or clinical auditing role required

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

  • Mastery of 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

  • Dedication to a growth mindset

  • 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

  • Dependent on experience level, position may be hired at a Senior level.

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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do 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. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

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

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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Primary Work Location

USA NJ - Franklin Lakes

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