Job Description Summary

SUMMARY
The Sr. Director, Quality Management Systems establishes, directs and ensures that all change management, document control, training, compliance, complaint management, Pharmacovigilance Operations (adverse event reporting for pharmaceutical/medicinal products), internal audit, CAPA and management reporting activities are in compliance with the FDA Quality System Regulation, other FDA Regulations, ISO and other international regulations and BD policies and procedures that apply to devices and drug products manufactured by or for the Surgery Business Unit. Additionally, the Sr. Director, Quality Management Systems functions as a subject-matter expert for document control, change control, training, internal audits, Notified Body assessments, FDA audits, adverse event reporting, post-market surveillance, and quality systems compliance. This position is key in developing the compliance strategy for Surgery and represents Surgery in the Segment and BD Corporate initiatives.

This position is based in Warwick, RI or Vernon Hills IL, but other BD sites may be considered.

Job Description

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.

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 will be supported to learn, grow, and become your best self. Become a maker of possiblewith us!

The Sr. Director, Quality Management Systems establishes, advises and ensures that all change management, document control, training, compliance, complaint management, Pharmacovigilance Operations (adverse event reporting for pharmaceutical/medicinal products), internal audit, CAPA and management reporting activities are in compliance with the FDA Quality System Regulation, other FDA Regulations, ISO and other international regulations and BD policies and procedures that apply to devices and drug products manufactured by or for the Surgery Business Unit. Additionally, the Sr. Director, Quality Management Systems functions as a subject-matter expert for document control, change control, training, internal audits, Notified Body assessments, FDA audits, adverse event reporting, post-market surveillance, and quality systems compliance. This position is key in developing the compliance strategy for Surgery and represents Surgery in the Segment and BD Corporate initiatives.

Responsibilities:

• Surgery Business Unit Functions – the following functions are traditional to Quality Management Systems leadership role:
  • Quality Systems – Directs the Surgery-wide strategy for the Quality Management System in compliance with regulations and standards around the world.  Ensures process owners are defined and coordinates continuous improvement in QMS procedures and work instructions.  Leads and supports projects to integrate Surgery and BD QMS policies, procedures and practices based on coordinated BD Integration Program plans and schedules.  Conducts required Management Reviews of key quality and performance data to ensure the quality system is adequate and effective.
  • Document Control - Directs the Surgery-wide document control activities to ensure all applicable documents are controlled and revision histories maintained.  Serves as business owner for the EDMS.
  • CAPA - Directs the Surgery-wide activities to ensure corrective and preventive action is appropriately applied to ensure products and processes address key issues and process improvements.  Reviews and approves CAPA investigations, root cause analyses, corrections, corrective actions, preventive actions and any necessary schedule extensions. Serves as business owner for the TrackWise electronic system.
  • Situation Analysis/Field Actions - Directs the activities to ensure adequate documentation for the assessment of field issues or conditions that must be considered for field action/recall decisions, escalates those decisions to the Segment level when required and ensures the implementation the field action execution when required.
  • Complaint Handling - Directs the Surgery-wide complaint activities to ensure regulatory requirements are fulfilled for complaint intake, complaint investigation, analysis of returned product to confirm complaints and determine root causes, coordinating manufacturing DHR reviews and ensures required MDR/Vigilance reporting.  Serves as business owner for the TrackWise complaint handling electronic system.
  • Post Market Surveillance - Directs the activities to comply with regulatory requirements for post-market surveillance of Surgery products on the required schedule for adequacy of product instructions for use, risk management, clinical performance and other key factors.
  • Pharmacovigilance (PV) Operations- Provide leadership regarding PV activities to ensure accurate maintenance and reporting of adverse drug events and other critical safety and PV data as required by regulatory agencies.
  • Compliance and Internal Audit - Directs the activities for conducting internal audits across the Business Unit and manages all external audits by Notified Bodies, FDA and other Competent Authorities world-wide.
  • Analytics - Directs the activities to ensure adequate trend analysis and statistical monitoring of complaints, supplier data, manufacturing data and other key reports for regulatory requirements and Surgery leadership visibility
• Represents the Corporation, Business Unit and Quality Department in a professional manner.
• Delegated as Deputy Management Representative for the BDI Surgery Vernon Hills and Warwick sites with authority over and responsibility for the following as described in 21 CFR Part 820, MDR (EU) 2017/745, and other applicable standards and regulations.
• Delegated as the Management Representative and Person Responsible for Regulatory Compliance (PRRC) for the global business. 
• Conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
• Technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
• Post-market surveillance obligations are complied with in accordance with Article 10(10).
• Reporting obligations referred to in Articles 87 to 91 are fulfilled.
• In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
• Provides strategy for Quality Systems, to include document control, training, internal audits, compliance, complaint management, CAPA, post market surveillance, and continuous improvements.
• Creates, reviews and approves Quality System Documents.
• Analyzes audit non-conformances and implements comprehensive & systemic corrective and preventive action plans.
• Ensures compliance to Business Unit, Segment and applicable Corporate procedures.
• Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards / changes are incorporated into Business Unit strategy.
• Tracks and trends Quality Indicators.
• Ensure post-market surveillance activities are scheduled and executed on time to support continue commercialization of Surgery products.
• Interfaces with Surgery manufacturing facilities as well as other Segment and Corporate functions.
• Establish the systems and processes for receiving, handling, investigating complaints including the assessment tools for determining and reporting MDRs.
• Interacts with other manufacturers to establish complaint handling, adverse event reporting, and distributor reporting responsibilities.
• Executes on Quality Key Driver Goals as approved by the Surgery Leadership Team.
• Respond to interrogatories, collection of documents and participate in depositions.
• Ensures maintenance all required records for the QMS.
• Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department. 
• Provides leadership for the overall CAPA process and all non-product CAPAs.
• Analyzes internal quality systems and associated data to assure adherence to QSRs, ISO, and other international standards, Corporate quality standards, and Business Unit and Facility quality standards.
• Develops, reviews and maintains Quality Policies for the Business Unit.
• Reviews Corporate Quality audit reports and prepares appropriate corrective action responses.

Qualifications:

• B.S. and equivalent experience, advanced degree is preferred.
• American Society of Quality (ASQ) certifications (CQE, CQA, CMQ/OE, etc.) preferred.
• Minimum 10+ years of experience with FDA regulated industry including experience with warning letters and other regulatory actions.
• Minimum 5+ years of managing a professional staff, including managers and supervisors.
• Ability to independently perform work of a broad nature. 
• Extensive knowledge of medical device regulations, industry or international standards and ability to interpret and implement. 
• Ability to understand Corporate, Business Unit and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency at the Business Unit & Plant levels.
• Ability to interface with regulatory bodies to defend Surgery compliance.

• Understands basic applied statistics, statistical sampling plans, and statistical process control.
• Ability to serve in leadership capacity on projects or assignments.
• Comprehensive understanding of auditing principles and ability to perform as a lead auditor.
• Ability to participate and provide leadership on teams and maintain positive work environment with those teams.  Understands team functions, leadership techniques and project management methodologies.
• Broad knowledge of medical device / pharma manufacturing processes. 
• Excellent communication skills (verbal, written, and presentation).  Understands how to present information to varying levels within the organization.
• Ability to effectively manage time and resources.
• Travel may be required at 30-40% to support sites across the Busines Unit

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. 

Required Skills

Optional Skills

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Primary Work Location

USA RI - Warwick

Additional Locations

USA IL - Vernon Hills

Work Shift