B. Braun

Associate Director, QA/Matl Mg

Job Locations US-PA-Breinigsville
Requisition ID
2021-19423
Company
Aesculap Biologics
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
Monday - Friday, 8:00 AM - 5:00 PM
Site
Aesculap Biologics

Overview

Aesculap Biologics, LLC, was established in January 2012 as a division of Aesculap, Inc. and is focused on biological approaches to the repair and regeneration of diseased or damaged tissues. Using a combination of cells, growth factors and smart biomaterial devices, Aesculap Biologics products can stimulate and support the synthesis of new tissue and enhance the body’s own regenerative power to improve the quality of patients lives.

Responsibilities

Position Summary:

 

Responsible for the development, implementation, and maintenance of the Aesculap Biologics (AB) Quality Management Systems required for the manufacturing, testing, and release of AB products. Ensures that AB activities meet the cGMP and GTP regulations as well as applicable state regulations.  Determines product standards; examine products and processes; and insures the quality and safety of clinical products.  Oversee compliant cold chain shipping logistics that includes packaging, tracking and documented transportation / distribution of human tissue and biologic materials between the AB manufacturing facility and clinical sites.  Ensures compliant procurement, receipt, and inspection of incoming cGMP raw materials, tissue, and consumables per applicable AB policies and procedures.  This position is responsible for product safety and quality and has a direct impact on patient safety.  All job functions must be carried out responsibly, competently, and in compliance with the AB Quality Management System to ensure that AB products are safe and effective.

 

Principal Duties Responsibilities: 

 

  • Acts as Management Representative with the authority to enforce cGMP/GTP compliance and reject/accept materials and product.
  • Develops, implements, and maintains the AB Quality Management System and Quality Policy Manual in compliance with the cGMP/GTP.
  • Oversees the quality assurance and materials management functions relating to the procurement, processing and release, packaging, material movements, and distribution of cell based biological products.
  • Assures the safety and quality of Aesculap Biologics’ products.
  • Writes, reviews and approves SOPs, batch records and other controlled documentation.
  • Acts as primary quality interface with FDA and other regulatory agencies conducting facility audits.
  • Management representative for the AB Quality Management System.
  • Conducts / coordinates quality system training; works closely with Manufacturing and QC Laboratory Managers to ensure overall training program is established and followed.
  • Oversees AB qualification / validation, preventive maintenance, and calibration programs.
  • Establishes and maintains the internal / supplier audit programs.
  • Serves on AB project teams.
  • Responsible for hiring, training, performance, and development of quality assurance and materials management staff.
  • Provides input for performance reviews of Manufacturing and Quality Control Staff relevant to cGMP/GTP compliance.
  • Guides the Quality Assurance / Materials Management departments and provides support to all the departments for quality and compliance.
  • Develops QA and materials management policies to be applied by all GMP Departments.
  • Continuously improves the AB Quality Management System including SOPs, Validation, Auditing, Product Release, Training, Documentation, Deviation Reporting, CAPA management, Batch Release, and materials management processes.
  • Regularly and systematically evaluates the trends of products (Product Reviews) providing reports for Management Review.
  • Manages Inspections by federal and state health authorities
  • Ensures that all organization's activities and operations are carried out in compliance with regulations and laws governing GMP/GTP operations.
  • Must comply with applicable ISO and FDA regulations as stated in Quality Manual
  • Must embody the Company’s Vision, Mission and Values
  • Other duties may be assigned
  •  

Secondary or peripheral job functions: 

 

  • Contribute to creating a climate of trust, ethics, and accountability by effectively seeking out and accepting feedback from others.
  • Possess the ability to exceed expectations with the customer in mind and take responsibility for driving key results as well as empower others to achieve desired outcomes.
  • Demonstrate behaviors that drive efficiency by understanding and improving processes as well as sharing best practices.

 

Supervisory Responsibilities:

 

  • Carries out supervisory 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 problem.

Job Specifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Qualifications

Education/Experience: 

  •  Bachelor’s degree in biological sciences required as well as Master’s degree.
  • 8+ years’ experience developing and monitoring Quality Systems in an FDA-regulated environment, preferably biologics or cell therapy.
  • Previous managerial experience is required.
  • Thorough knowledge of GMP/GTP/QSRs and materials management activities including procurement, supplier quality management, receiving, inspection, release, and distribution.
  • Previous experience in sourcing critical raw materials and qualifying domestic and international suppliers is preferred.
  • Working knowledge of SAP is a plus.
  • ASQ CQA / CQM / CQE is required.
  • Excellent interpersonal skills and the ability to work and manage effectively in a team environment.
  • Highly organized with the ability to manage complex projects.

Language and mathematical skills; reasoning ability:

  • Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.  Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.  Ability to effectively present information to top management, public groups, and/or boards of directors.   
  • Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals.  Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. 
  • Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. 

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.

B. 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.

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

Other

Responsibilities: Other Duties:

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.  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 finger, 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. 

 

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.  This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees. The noise level in the work environment is usually moderate.

Notices

Equal Opportunity Employer Veterans/Disabled

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