B. Braun

  • Director, Quality

    Job Locations US-PA-Allentown
    Requisition ID
    2018-12669
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    8am to 5pm
    Site
    Allentown, PA
  • Overview

    With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.

     

    U.S. Facilities and Operations:

     

    Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.

    Responsibilities

    Position Summary:

    Direct the development and implementation of B. Braun Medical Inc. Quality Systems and programs to ensure compliance with company policies and procedures, and industry regulations and standards, including FDA QSR, ISO 13485:2003 (medical device specific), CMDR, CFRs, and cGMPs. Oversee Quality Assurance and Quality Control functions to work with other departments in the development of new products, processes and controls and to solve technical or quality related problems. Provide technical assistance and direction to Engineering/Validation in the areas of chemistry, microbiology and physical testing of components and materials, including APIs and excipients (Irvine specific) to ensure adherence to quality control objectives. Ensure compliance and inspection readiness of quality system and manufacturing facilities with applicable regulatory standards.

    Responsibilities: Essential Duties

    • Execute management responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Select, train, motivate and develop a highly technical staff with experience in a wide variety of disciplines to accomplish both the department’s and the site’s objectives. Responsible for the overall direction, coordination and evaluation of the reporting departments and functions.
    • Ensure Quality Systems are established and maintained in harmony with Corporate Operating Procedures and in accordance with applicable standards and regulations. Report on the performance of the Quality Systems to Executive Management. Lead quality improvement efforts to further enhance quality systems, resolve top quality issues and mitigate compliance risk.
    • Conduct management meetings to establish, delineate, and review program organizational policies, to coordinate functions and operations between departments and to establish responsibilities and procedures for attaining objectives.
    • Review technical problems and procedures, monitor field complaints and production problems and recommend solutions to problems or changes in procedures. Direct the investigation of excursions in manufacturing operations resulting in abnormal operation rejections. Determine root cause(s), products/materials affected, disposition of products/materials affected, implement both corrective and preventive actions, and monitor effectiveness of those actions.
    • Build and foster strong relationships and partnerships with stakeholders and support groups worldwide to meet the demands of a changing business culture and environment.
    • Lead the site during any regulatory agency inspection and ensure timely responses to any issues which may be identified.
    • Direct investigations for customer complaints and ensure responses are provided to customers. Review complaints to determine if they are reportable. Identify when field action such a product holds, product advisories and product recalls are needed for items already in use by customers.
    • Ensure new products and processes are qualified and/or validated prior to approving their release for distribution to customers. Ensure products manufactured by B. Braun are tested to ensure product safety, quality and effectiveness and are released with established timeframes required to meet company operating objectives. Monitor the quality of products and implement systems and strategies to ensure products continue to conform to established specifications.
    • Establish goals and objectives for Quality department that are consistent with site’s Operations Objectives and Corporate Quality Objectives. Translate goals and objectives into personnel performance objectives.
    • Develop and execute the budget/profit plan required to meet production and profit plan goals, and assure costs are maintained within constraints of budget. Assist in development and implementation of capital budget to ensure facilities and equipment are sufficient to support plant and department goals and objectives.
    • Develop or review all training programs to assure their adequacy, repeatability, effectiveness, as well as consistency between sites, as applicable.
    • Drive continuous improvements efforts for products and quality systems. Lead and coordinate the efforts within the entire operation to formulate and implement effective corrective and preventive actions to the internal and external assessments, adverse trends and quality issues.
    • Conduct periodic audits and plant walk-throughs to ensure compliance to cGMPs, Pharmaceutical Elegance (Irvine specific), and inspectional readiness.
    • Chair Quality Management Reviews to ensure management involvement, visibility to quality issues, and proper quality oversight of site Operations.Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures.
    • Responsible to review and approve quality investigations to ensure documentation is complete, accurate and timely.
    • Function as Management Representative.

    Expertise: Knowledge & Skills

    • Statistical sampling and quality control methods
    • Hypothesis testing
    • Design of experiments
    • CGMP’s, QSR’s, ISO, CMDR, and MDD
    • Statistical sampling plans
    • General knowledge of human physiology
    • Risk Management and Hazard Analysis techniques
    • Data analysis
    • Motivation methods
    • Knowledge of budgeting principles and general administrative practices
    • Thorough knowledge of management principles and supervisory practices
    • Leadership – Must exercise leadership and move others to action; this includes peers and superiors, as well as subordinates. He/she needs to demonstrate a positive, results-oriented style by planning, motivating, organizing and controlling the work being done.
    • Promotion – He/she should have the capacity to grow and take on additional responsibilities.
    • Interpersonal Skills – Able to foster excellent relationships and credibility quickly at all levels of the organization, as well as the ability to create a partnership atmosphere with internal and external resources while achieving key operating objectives.
    • Business Acumen/Competitive Knowledge – He/She needs to maximize opportunities and advantages and search for ways to leverage the current position.
    • Integrity – A professional of unquestionable integrity, credibility and character who has demonstrated high moral and ethical behavior.
    • Communication – Ability to develop and articulate an effective flow of ideas and information that generates an understanding and creates a climate in which others are informed and want to participate.
    • Planning and Analysis Skills– He/She must have the ability to analyze and grasp an entire situation quickly from many perspectives and to create well-reasoned solutions. He/she needs to be conceptual, able to recognize problems from few or subtle clues and be innately comfortable with complexity. He/she should be able to demonstrate a probing, analytical approach.
    • Training/Coaching Skills – Able to foster the professional development of subordinates through coaching/feedback on results, willing and able to share personal knowledge/experience and able to move decisively with performance problems.
    • Maturity – Ability to be aggressive and confident, thus providing a good balance of risk taking and judgment.

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

    Required:

    • B. S. in Scientific discipline
    • 10-15 years of experience in the pharmaceutical/medical device industry
    • Three years experience in a QC/QA leadership role required
    • Five years experience in quality assurance
    • In-depth knowledge of all QC/QA activities and regulatory requirements in the pharmaceutical/medical device industry, preferably involving IV solutions/injectable drugs (Irvine specific).
    • Ability to develop leaders and appropriately staff Quality organization to meet business needs and succession plans
    • Financial acumen (e.g. budgetary, capital spending, etc.)
    • Leadership in partnering with Manufacturing, R & D, and Engineering.
    • Experience in FDA inspections and strategy
    • Ability to use sound scientific judgment in management of the facility to prevent regulatory action
    • Demonstrated track record in managing a large staff and establishing a clear, strategic direction
    • Understanding of cGMP’s and an ability to interpret and enforce regulatory requirements
    • Travel to any B.Braun facility, domestic and internationally.
    • To keep abreast of changes in the regulations, interpretation of the regulations and revising internal practices and written procedures to comply with the regulatory requirements.

    Desired:

    • Advanced degree (M.S., M.B.A., Ph.D.)

    While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

     

    Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com Equal Opportunity Employer Minorities /Women/ Veterans/Disabled

    Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

    Other

    Responsibilities: Other Duties:

    The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

    Physical Demands:

     The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Work Environment:

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

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