BD (Becton, Dickinson and Company) Clinical Quality and Compliance Manager in Franklin Lakes, New Jersey

Job ID: 2018-12366

Career Level: management

Relocation: Yes

Location: Franklin Lakes,New Jersey,United States

Summary of Position with General Responsibilities:

The Manager, Clinical Quality and Compliance is responsible for leading activities that result in being an organization that is “Audit Ready”. The individual will report directly to the Director Clinical Quality and Compliance. The primary responsibilities include: Leading the Clinical Quality Assurance Program, Supporting Vendor qualification and management activities, investigation of high risk quality concerns, and providing interpretation and applicaiton of current and upcoming regulations in the industry.

Essential job Functions:

  • Develop and execute risk based quality assurance strategies to support the Global Clinical Operations activities, which include assessment / audit planning, conduct, documentation and follow up of planned activities

  • Maintain knowledge of FDA and other regulatory agencies’ (e.g., European agencies) activities, regulations and guidelines relevant to Clinical Affairs

  • Monitor relevant agency compliance rulings and communications

  • Provide expertise and guidance to collaborating departments in interpreting and implementing government and agency guidelines to assure GxP compliance

  • Lead role in supplier/vendor qualification and compliance oversight process

  • Develop, implement, and execute the GxP compliance auditing program to ensure the fulfillment of regulatory requirements

  • Review and monitor Corrective Action Plans identified internally and/or externally and assist in root cause analysis and formulating responses

  • Support regulatory inspections of Sponsor, GCP sites and GxP vendors

  • Support the Quality Planning Process and risk profiling activity & mitigation approaches during the study life-cycle

  • Support the management of quality systems & continuous improvement.

  • Interact and develop relationships with vendors’ quality leaders through audits, project teams, and established one-on-one relationships

  • Write GxP Quality SOPs in support of the Clinical Quality SystemsEnsure compliance with corporate policies and procedures as well as US healthcare laws and regulations through ongoing assessments during the conduct of studies

  • Identify additional capacity needs in the audit activity, assist in sourcing, and train incumbents on internal SOP’s related to the audit program

  • Development and maintenance of written internal procedures for clinical assessments and associated templates

  • Produce training material and conduct training sessions regarding compliance to policies, procedures, standards and regulations

  • Participation in external committees (e.g., AdvaMed) as requested

Basic Qualifications:

  • Minimum ten years medical device and/or pharmaceutical experience, with significant device experience in Clinical Affairs

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

  • Minimum 5 years performing supplier/vendor qualifications and audits

  • Advanced knowledge of and experience of with all regulations, and relevant standards (e.g., FDA, ISO, MDR, IVDR GDPR)

Additional Desirable Qualifications Skills and Knowledge:

  • Knowledge of and experience with O-US country related regulations

  • Knowledge of processes related to Clinical Affairs Data Management and Biostatistics functions

  • Experience in Regulatory Affairs and/or Quality department

  • ASQ certification, IRCA or other relevant auditor certification a plus

  • Effective communication skills both verbal and written

  • Ability to work independently with minimal supervision and accountable for managing multiple studies concurrently

  • Demonstrates leadership abilities

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

  • Anticipates problems, issues, and delays; proactively looks to minimize the impact of identified compliance issues

  • Multi-disciplinary knowledge across functional areas

Education and/or Experience:

  • Bachelor’s Degree in the sciences or engineering

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