Job Description Summary The Senior Director, Division Quality Management establishes, directs and continuously improves Division functions including Quality Systems, Document Control, CAPA Management, Field Action Support, Complaint Handling, Post Market Surveillance, Compliance, Internal Audit, Quality Analytics and Supplier Quality and Operations Quality Multi-Site Director functions, including the Covington Analytical Lab, Covington Kitting and IQC Quality and Regional Sterilization Quality at Covington and Madison sites in compliance with the FDA Quality System Regulation, other FDA Regulations, ISO and other international regulations and Bard/BD policies and procedures that apply to devices designed and manufactured by UCC. Additionally, the Sr. Director, Division Quality Management functions as a subject-matter expert for MasterControl, Change Control, Training, Internal Audits, Notified Body assessments, FDA audits, adverse event reporting, and quality systems compliance. This position is key in developing compliance strategy for UCC and represents UCC on the Segment Compliance Council. Job Description
This position has an organization of over 120 people, including permanent associates, temporary workers and consultants.Division Functions
- The following functions are Division-level Quality Management leadership activities:
- Quality Systems- Directs the Division-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 UCC and legacy Bard policies, procedures and practices with BD's QMS 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 Division-wide document control activities to ensure all applicable Division documents are controlled and revision histories maintained. Serves as business owner for the MasterContol electronic system.
- CAPA Management- Directs the Division-wide activities to ensure corrective and preventive action is appropriately applied to ensure products and processes address key field 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.
- SA/Field Action Management- Directs the activities to ensure adequate documentation for the Division's assessment of field issues or conditions that must be considered for field action/recall decisions, escalate those decisions to the Segment level when required and implement the field action execution when required.
- Complaint Handling- Directs the Division-wide Field Assurance activities to ensure regulatory requirements are fulfilled for complaint intake, complaint investigation, analyzing returned product to confirm complaints and determine root causes, coordinating sterilization and manufacturing DHR reviews and ensures required MDR/Vigilance reporting. This team manages over 21,000 complaints and 8,400 MDR/Vigilance report submissions per year, the largest volume in the BDI Segment. 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 Division products on the required schedule for adequacy of product instructions for use, risk management, clinical performance and other key factors.
- Compliance and Internal Audit- Directs the activities for conducting internal audits across the Division and managing all external audits by Notified Bodies, FDA and other Competent Authorities world-wide.
- Quality 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 Division leadership visibility.
- Division Supplier Quality- Directs the Division-level supplier quality program to ensure R&D, Manufacturing and service providers are appropriately classified for risk, conducts supplier audits and assessments, ensures Quality Agreements established to appropriately maintain suppliers on the UCC Approved Supplier List. This includes over 230 suppliers and more than 70 assessments and audits per year.
- The following functions representsignificant expansionof this position unique to this UCC position beyond traditional Division Quality Management leadership roles in other Divisions and companies:
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Covington Analytical Lab- Directs the activities for analytical lab which performs over 13,000 chemistry and microbiology tests per year and consulting for the design and manufacturing facilities across the BDI Segment.
- Covington Kitting and IQC Quality- Directs the Division incoming inspection of 5,200 lots annually of raw materials and components for kitting and other receipts and directs the Quality activities for the production kitting of 4200 lots of 2,600,000 units annually and rework of more than 300,000 units annually for other BDI Divisions.
- Regional Sterilization Quality- Directs the Quality activities for product sterilization in Covington and Madison facilities for a combined volume of more than 235 Million units per year supporting all legacy Bard Divisions and recently added legacy BD Divisions. All BDI Segment products requiring EtO sterilization is processed through these Regional Sterilization facilities.
include the following. Other duties may be assigned.
- Represents the Corporation, Division and Quality Department in a professional manner.
- Participates on Compliance Council as UCC Representative.
- Provides strategy for Quality Systems, to include Document Control, Training, Internal Audits, Compliance, complaint management, CAPA and continuous improvements.
- Creates, reviews and approves Quality System Documents.
- Develops staff.
- Analyzes audit non-conformances and implement comprehensive & systemic corrective and preventive action plans.
- Performs Internal Quality System Audits.
- Ensures compliance to Department and Division procedures.
- Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards / changes are incorporated into division strategy.
- Tracks and trends Quality Indicators.
- Interfaces with Bard manufacturing facilities or other Division functions.
- Establish the systems and processes for receiving and handling complaints.
- Establish the systems and processes, including the assessment tools for determining and reporting MDRs.
- Coordinates the review, investigation, and corrective actions of product complaints with manufacturing source Quality Assurance personnel to ensure consistency and attention to detail in performing and documenting complaint evaluations.
- Interacts with other manufacturers to establish complaint handling, adverse event reporting, and distributor reporting responsibilities.
- Interprets corporate policies and regulations as to how they relate to Field Assurance, and prepare and implement Divisional procedures for conformance.
- Ensures the accuracy and efficiency of complaint documentation from the initial receipt of a product complaint and opening of a complaint file to the closure of the file.
- Manage complaint turnaround times and corrective action follow-up.
- FDA-MDR contact for responding to FDA inquiries.
- MHRA-MDR contact for responding to MHRA inquiries.
- Ensures that all complaints on products marketed by UCC and any of its associated business groups are received, documented, analyzed, and trended in accordance to Corporate and Divisional policies and procedures, and applicable regulations.
- Coordinate worldwide exchange of complaint information.
- Communicate complaint trends.
- Functions as Product Litigation Coordinator and interacts with Corporate Legal in responding to litigation requests, reimbursement requests, and evaluation results requests for UCC.
- When required, respond to interrogatories, collection of documents and participate in depositions.
- Maintain all required records for the complaints and/or MDR Reports.
- Train customer facing staff, such as sales staff, on the complaint system and internal reporting procedure.
- When sales training materials involve questions of safety or indications, review and approve the sales force training materials.
- 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.
- Maintains and enhances UCC Capital Equipment compliance to ISO requirements and other international regulations.
- Analyzes internal quality systems and associated data to assure adherence to QSRs, ISO, and other international standards, Corporate quality standards, and Divisional and Facility quality standards.
- Develops, reviews and maintains Quality Policies for the Division.
- Reviews Corporate Quality Audit Reports and prepares appropriate corrective action responses.
To perform this job successful, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this section and below are representative of the knowledge, skill and/or ability required.
EDUCATION and/or EXPERIENCE
- 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, Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency at the Division & Plant levels.
- Ability to interface with regulatory bodies to defend UCC compliance.
- Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi.
- 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 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.
- Ability to handle multiple project assignments.
- B.S. Engineering or equivalent experience, advanced degree is preferred.
- American Society of Quality (ASQ) certifications (CQE, CQA, CMQ/OE, etc.) preferred.
- Minimum 20 years of experience with FDA regulated industry including experience with warning letters and other regulatory actions.
- Minimum 10 years of managing a professional staff, including managers and supervisors.
- Ability to read, analyze, interpret and present business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to read, analyze, interpret and present business data and results.
- Ability to write reports, business correspondence, and procedure manuals.
- Ability to effectively present information and respond to questions from varying levels and functions of the organization.
- Well versed in English language skills, both verbal and written.
Well versed in statistics, analytical reasoning skills based on data.REASONING ABILITY
- Highly variable operations performed daily from complex regulatory and engineering decisions to routing administrative functions. Interpretation of regulations (QSR, ISO requirements, EN46001) into standards and procedures as required. The ability to explain these interpretations to Plant, Division, Corporate and representatives of Regulatory bodies is necessary.
- Individual is looked upon as a decision-maker, one of high integrity and decision-making skills. Decisions made by this person could have significant regulatory and financial implications. Furthermore, this person's decisions could have a significant impact on health care practitioners and the welfare of their patients.
- A great deal of self-directed work must be initiated through a detailed knowledge and understanding of the division products and processes. There is a great deal of freedom of action, originality and imaginative drive and critical analysis since there is not strict day-to-day supervision. The success of implementation of quality plans is largely dependent upon the person's ability to recognize the most efficient, cost effective and strategic approach to attaining the desired goal. In many instances, the person will be required to use creativity and imagination in carrying out the job function. This person will be working in a fast-paced, technically challenging environment where drive is critical to success.
Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects up to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.WORK ENVIRONMENT
This position works in a normal office environment. The noise level in the work environment is quiet to moderate.
Travel may be required. Travel may include visits to manufacturing, Division, Corporate & clinical sites or hospitals.
Primary Work LocationUSA GA - Covington BMD Additional Locations Work ShiftNA (United States of America)
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.