B. Braun

  • Sr. Quality Systems Program Manager

    Job Locations US-CA-Irvine
    Requisition ID
    2018-13216
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    8:00am- 5:00pm
    Site
    Irvine, CA
  • 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:

     

    Lead efforts to redesign and deploy a compliant, efficient and effective Quality Management System (QMS) for the site that emphasizes an integrated approach to quality risk management. Provide experiential guidance, subject matter specialty, and optimized standard industry practices in QMS to meet pharmaceutical current Good Manufacturing Practices (cGMP). 

     

    Responsibilities: Essential Duties

    • Lead and participate in efforts to redefine the QMS for a mature organization focused on pharmaceutical product development and high volume commercial manufacturing.      
    • Work collaboratively with business process owner, site leadership team and the Corporate Quality team to plan and execute quality system program. Identify, coordinate and track project schedules, tasks and dependencies. Establish and maintain communications through use of tracking and status reporting tools. Identify and manage issues and risks and facilitate timely decision making that assures an efficient, effective and compliant QMS.
    • Ensure adherence to 21 CFR 210, 211, ICH guidelines, and the Company’s Quality System policies and procedures.
    • Analyze existing procedures and processes to identify existing best practices.       Assure integration of internal and external industry best practices into the future state QMS.
    • Support the design and implementation of a robust and compliant framework of cGMP procedures.
    • Collaborate with Training to assure that appropriate individuals are trained on changes in the QMS in accordance with company policies.
    • Work seamlessly with functional business groups to drive continuous improvement in system integration, interfaces with business processes, and efficiencies to ensure effectiveness quality system is maintained.
    • Establish and integrate metrics necessary to assure sustainability of quality system elements.
    • Build and foster strong relationships and partnerships with stakeholders and support groups to meet the demands of a changing business culture and environment.
    • Serves as a key quality systems subject matter expert to the organization. Participate in organizational training to drive organizational competency in quality system requirements.  
    • Performs other related duties as required by management.

    Expertise: Knowledge & Skills

    • Strong working knowledge of ICH Q10, “Pharmaceutical Quality Systems”, and ICH Q9, “Quality Risk Management”
    • Project Management experience is required, including project initiation, team development, and achieving desired results on time and on budget.
    • Solid understanding of the efficiencies and criticalities of all of the quality systems elements.
    • Ability to use sound scientific judgment and risk-based decision making
    • Ability to proactively identify and anticipate risk of non-compliance in a dynamic environment
    • Ability to make verbal presentations to both small and large groups at a variety of levels both inside and outside of the company.
    • Strict attention to detail required.  
    • Leadership in partnering with Operations, R&D, Engineering, Supply Chain, Regulatory and Scientific Affairs, Sales and Marketing, etc.

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

     

    Required:

    • Bachelor’s Degree
    • 8+ years of developing and managing Quality Systems within pharmaceutical company(s)
    • 4+ years experience in a quality leadership role
    • In-depth knowledge of quality systems and how quality systems are designed and operated to satisfy regulatory requirements in commercial GMP operations. 
    • Travel to any B. Braun facility, domestic and internationally, when necessary.
    • 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.)

    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 30 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 employee must occasionally lift and/or move up to 30 pounds.

    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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