Manager II , Quality Compliance
Location:
Irvine , California
Posted:
September 03, 2016
Reference:
2016-8733
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:

Provide quality audit and regulatory compliance expertise for pharmaceutical manufacturing and quality processes and related products within Irvine Operations. Ensure internal site compliance to applicable regulations, standards and quality systems and through direct interactions across all functional lines and periodic auditing. Establish guidelines and requirements for quality and regulatory compliance in supporting special projects and ongoing operations.

Responsibilities: Essential Duties
  • Serves as a quality and regulatory compliance expert to the B. Braun Irvine Operations. Maintains comprehensive knowledge of applicable quality and regulatory requirements and their interpretation.
  • Assist in the development and support of the company audit program (internal, supplier, customer and regulatory) to ensure timely and effective corrective/preventative actions are developed, implemented and verified to resolve audit observations, while maintaining compliance with applicable FDA Quality System Regulations and industry standards and meeting/exceeding current industry practices. Serve as the key leader within the site to establish, implement and maintain audit readiness program.
  • Develop, review and verify responses to regulatory agency findings or internal and/or customer observations.
  • Support Operations to develop requirements for external supplier qualification and ongoing assessments for the manufacturing, laboratories and services areas.
  • Provide guidance and regulatory advice during the development, implementation and effectiveness verification of the corrective/preventive actions according to the established procedures and established action plans.
  • Supports/hosts external audits, compliance inquiries and/or surveys.
  • Develop, track, trend and report to management on compliance metrics. Identify, communicate and escalate to Executive Management, as required, compliance issues and risks for further comprehensive action.
  • Participate in the development and execution of quality/regulatory-related training and education.
  • Identify, develop and implement quality system improvements when gaps are identified through audits, gap analysis and quality system management reviews.
  • Provide support in collaboration with Manufacturing and Quality Operations for the investigation and root cause analysis of product, process and quality systems gaps, deviations and discrepancies.
  • Provide support for product impact assessments when gaps, deviations and discrepancies in processes and quality systems are identified
  • Work interactively with cross-functional teams to achieve company business and quality goals/objectives.
  • Ensure operations within approved department budget.
  • Stay abreast of evolving regulatory and industry standards trends that are relevant, and ensure that appropriate action is initiated and communicate these trends to applicable personnel.
  • Ensure compliance to applicable regulations and standards including, but not limited to cGxP, ISO, MDD, ICH, and USP.
Expertise: Knowledge & Skills
  • Very good working knowledge of Pharmaceutical (21 CFR 210 & 211)
  • Good working knowledge of FDA/cGMP, ISO, CE, UL, CSA requirements
  • Excellent computer and PC skills including experience with MS Office applications, database and statistical applications
  • Sufficient human relations and leadership skills to effectively staff and manage relevant personnel, including external consultants, and functions to assure that company goals and responsibilities are met.
  • Word Processing, Statistical and Database applications.
  • Ability to act effectively as a member of a team to resolve problems.
  • Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time.
  • Ability to investigate and analyze technical and regulatory issues.
  • Excellent oral and written skills.
  • Strong interpersonal skills.


Qualifications: Expertise: Qualifications - Experience/Training/Education/Etc

Required:
  • BS degree in technical or scientific discipline and eight or more years of related experience preferably in the pharmaceutical or medical device industry.
  • Experience in auditing for performing and hosting internal audits, supplier audits, 3rd party audits (OEM), FDA/ISO regulatory inspections.
  • Experience with cGMP's and FDA guidelines.
  • Valid driver license and current passport required
  • Able to travel approximately 10% per calendar year
Desired:
  • Certified Quality Auditor (CQA) Preferred
  • MS in a related science
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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