Associate Director Quality Assurance

Location
Boca Raton, FL
Posted
May 22, 2021
Ref
26530
Required Education
Bachelors Degree
Position Type
Full time

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart.  If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics.  We currently have an exciting opportunity available for an Associate Director of Quality Assurance in Boca Raton, FL!

 

The incumbent will oversee the management of ADMA quality systems, third party organizations (vendors, contract manufacturers), the supplier quality program, and internal/external auditing to ensure adherence to policies and regulations.

 

RESPONSIBILITES

  • Management of the supplier quality program from vendor selection and qualification to routine management and SCARs as well as qualification and periodic vendor/contractor audits, including leading these audits as necessary.
  • Perform audits of contract manufacturers that test, produce and distribute raw materials, intermediates, and bulk materials for ADMA.
  • Responsible for the AQPR (internal Annual Product Quality Review) and QSRB (Quality Systems Review Board).
  • Leading the internal audit program to ensure adherence to ADMA policies and procedures and FDA regulations.
  • In-depth knowledge and experience with all major quality management systems, including deviations, change control, CAPA, and batch release so that they can be relied upon to review and approve such records in accordance with FDA regulations and ADMA polices.
  • Review and approve standard operating procedures, master batch records used in manufacturing, facilities and quality control used to produce clinical/licensed product.
  • Able to communicate directly with the FDA during routine and pre-approval inspections and support audit management.
  • Participate in the generation and review/approval of product BLA and other regulatory documents as needed.
  • Review and approve the validation protocols and summary reports of critical systems, cleaning, process(es), analytical methods in alignment with ADMA and FDA guidance.
  • Review stability protocols, summary reports, and associated data for accuracy and adherence to ADMA and ICH guidelines.
  • Able to lead deviation investigations related to materials, product or processes, and perform RCA and CAPA implementation.
  • Provide training on quality-related topics.
Qualifications

Education Requirements:

  • Bachelor's Degree in Biological Sciences, Chemistry, Biochemistry, Chemical Engineering or related field.

 

Experience Requirements:

  • 10-15 years of experience in a quality-related role, preferably in a biologics pharmaceutical manufacturer and in managerial level roles.
  • Detail-oriented with excellent written and verbal communication skills. 
  • Ability to use personal computer and software including Word, Excel, and Visio. 
  • In depth knowledge of federal guidelines (21 CFR) related to pharmaceutical manufacturing and, specifically, biologics pharmaceuticals.
  • A good working knowledge of standard biologics pharmaceutical production operations such as plant utilities, clean room requirements, and common production processes (column chromatography, centrifugation, viral inactivation, sterile filtration and aseptic filling, etc).

 

In addition to competitive compensation, we offer a comprehensive benefits package including:

  • 401K plan with employer match and immediate vesting
  • Medical, Vision, Life and Dental Insurance
  • Pet Insurance
  • Company paid STD and LTD
  • Company Paid Holidays
  • 3 Weeks’ Paid Time Off (within the first year)
  • Tuition Assistance (after the first year)
  • Easily accessible to Tri-Rail
  • Company paid shuttle to the Boca Tri-Rail station

 

 

ADMA Biologics, Inc. uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

 

ADMA Biologics is an Equal Opportunity Employer