Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryThe Sr. Director, Quality Assurance has the responsibility of providing strategic direction for and tactical management and oversight of the Surgery Business Unit’s manufacturing operations worldwide. This role establishes, directs, and ensures all plant quality functions including quality engineering, quality control, document control, training, sterilization, failure investigation, GMP auditing and supplier management meet worldwide regulations and standards, corporate polices, segment requirements, business unit and local procedures.
The Sr. Director, Quality Assurance functions as the interface between the manufacturing sites and the Surgery Leadership Team, the Surgery product platform teams, the segment and corporate leadership. This position is key in developing the compliance strategy for Surgery operations.
This role is responsible for plant Quality talent management including recruitment, selection, development, training and retention of Quality personnel at El Paso, TX, Humacao, Puerto Rico, Delran, NJ, Woburn, MA, Irvine, CA, St. Louis, MO, Cleveland, OH, and Wurmlingen, Germany. The incumbent ensures that proper quality skill sets, and competencies are consistent with business and technology plans.
This position has an organization of 200+ people, including permanent associates, temporary workers and consultants.
- Plant Functions – the following functions are reflective of the breadth of accountability this leadership role holds for compliant Quality Systems:
- Quality Systems – Works with the Director, Quality Systems to ensure the strategy for the Quality Management System is 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 manufacturing sites’ document control activities to ensure all applicable production and quality system documents are controlled and revision histories maintained per Surgery Business Unit policies and procedures.
- CAPA – Directs the manufacturing sites’ 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, as appropriate.
- Situation Analysis /Field Actions – Directs the activities to ensure adequate documentation for assessment of product concerns or conditions that must be considered for field action/recall decisions related to manufacturing issues, escalate those decisions to the Surgery Business Unit level when required and ensure CAPA investigations and corrective actions are implemented.
- Complaint Handling – Directs the activities to ensure complaint investigations, analysis of returned product to confirm complaints and determine root causes, and manufacturing DHR reviews are completed by plant quality associates are robust and completed to meet required complaint timeliness.
- Post Market Surveillance – Ensures plant quality associates comply with data requirements for post-market surveillance of Surgery manufactured products on the required schedule to maintain compliance to regulations for periodic reviews.
- Compliance and Internal Audit – Directs the activities for conducting internal audits across all manufacturing sites and managing all external audits by Notified Bodies, FDA and other Competent Authorities world-wide. Interfaces with the Surgery Business Unit Compliance Manager to effectively support the audit program.
- Analytics – Directs the activities to ensure adequate trend analysis and statistical monitoring of KPIs, statistical process controls, complaints, supplier data, additional manufacturing data and other key reports for regulatory requirements and Surgery leadership visibility.
- Manufacturing Operations – the following functions represent the accountability of this leadership role with regard to the worldwide Surgery manufacturing operations:
- Quality Control – Directs the supervision of incoming inspection, quality controls and quality release for Surgery products manufactured worldwide.
- Supplier Quality – Directs the supplier quality program for Surgery to ensure R&D, manufacturing and service providers are appropriately classified for risk; supplier audits and assessments are conducted; Quality Agreements are established to appropriately maintain suppliers on the Approved Supplier List.
- NPD and Technology Transfers – Directs the activities associated with transfers to manufacturing of all new product projects and technology changes. Ensures changes to current commercialized product is subject to robust review by R&D and Regulatory Affairs, as appropriate.
- State of the Art Technology – Drives new manufacturing technology upgrades and implementation by coordination with Manufacturing Operations and Finance to meet budget requirements.
- GMP Compliance – Accountable to ensure all worldwide manufacturing sites are compliant with good manufacturing practices, FDA and ISO regulations, as well as all other international regulations and laws governing the commercialization of Surgery product.
- Safety – Ensures all Quality associates contribute to a safe working environment by observing all plant safety rules.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Represents the Corporation, the Surgery Business Unit and Quality Assurance in a professional manner.
- Develops quality policies, annual goals, and objectives for manufacturing site Quality associates in conjunction with Surgery Business Unit goals and objectives.
- Establishes effective quality procedures and project plans for each NPD and technology transfer projects to ensure that FDA, Corporate and Global quality system requirements are met.
- Lead multi-site, multi-departmental teams to implement the quality strategies with respect to the collection, documentation, analysis, and reporting of quality data, key driver goals and Quality Indicators to drive corrective and preventive actions.
- Analyzes internal quality systems and associated data to assure adherence to QSRs, ISO, and other international standards, corporate quality standards, and business unit and plant quality standards.
- Establishes effective policies and procedures for incoming quality control (e.g., inspection protocols, re-inspections), manufacturing (e.g., production, testing, rework), materials management, labeling, and hold, release, reject, return to vendor, scrap, and Not for Human Use product disposition management along with maintenance of the quality system.
- Provides strategy for Quality Systems, to include document control, training, internal audits, compliance, complaint investigations, CAPA and continuous improvements.
- Analyzes audit non-conformances and implement comprehensive & systemic corrective and preventive action plans.
- Ensures compliance to corporate policies, segment and business unit policies and procedures, and local plant procedures.
- Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards / changes are incorporated into strategy.
- Interfaces directly with Surgery product platform functional leads to ensure alignment with strategy and implementation of initiatives to meet Surgery business goals.
- Directs 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. Ensures the investigations are completed in a timely manner to facilitate complaint closure.
- Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the Quality Assurance function at all manufacturing sites.
- Oversees and/or prepares appropriate responses and/or corrective action plans to observations for FDA, Notified Body and international regulatory authority inspections.
- Reviews corporate Quality Audit Reports and directs the preparation of 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.
- Ability to independently perform work of a broad nature.
- Extensive knowledge of medical device regulations, industry and 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 Plant levels.
- Ability to interface with regulatory bodies to defend Surgery’s state of compliance at the Plant level.
- Ability to control costs while providing appropriate resources to maintain compliance posture while meeting business needs.
- Ability to identify opportunities for quality and cost improvements.
- Broad knowledge of medical device manufacturing processes.
- Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi.
- Understanding and experience in Design Control requirements applied to medical devices.
- Fundamental knowledge of validation principles.
- Ability to serve in leadership capacity on projects or assignments.
- Comprehensive understanding of auditing principles.
- 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.
- Excellent communication skills (verbal, written, and presentation). Understands how to present information to varying levels within the organization.
- Ability to effectively manage time and multiple task assignments as well as managing team assignments and direction.
- Ability to handle multiple project assignments.
- Supports a strong culture of accountability and inclusion and seeks to develop team capabilities as well as foster personal growth.
- Travel up to 50%.
EDUCATION and/or EXPERIENCE
- 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 direct experience in manufacturing.
- Minimum 10 years of managing a professional staff, including managers and supervisors.
- Ability to read, analyze, interpret and present technical procedures and governmental regulations.
- Ability to read, analyze, interpret and present business data and results.
- Ability to write reports, business correspondence, and procedures.
- 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.
- 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, Business Unit, 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 Surgery’s 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.
This position works in a normal office environment and the manufacturing environment. Although this position has a base in Warwick, RI, this is a remote opportunity.
Travel will be required.
Primary Work LocationUSA RI - Warwick
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Advancing the world of health™
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