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Director of Quality Assurance

Blue Ash, Ohio
General Purpose of Position:
The position is responsible for leading and managing the site QA (Quality Assurance) operations to assure the quality of Aprecia Pharmaceuticals products.  This position is also responsible for the quality of products produced, tested, and packaged at the site. 

Primary Duties and Responsibilities (Essential Functions):
 
  Duties/Responsibilities
1 Lead and manage site QA operations and systems to ensure that the assessment of raw materials, packaging materials, in–process intermediates, and finished goods is performed consistent with cGMP (current Good Manufacturing Practices) and Aprecia Pharmaceutical standards
2 Serve as the site contact for regulatory authority visits – FDA (Food & Drug Administration), MHRA (Medicines and Healthcare products Regulatory Agency), etc. to the site, participate in regulatory investigational visits, and lead team in the preparation of site responses to FDA inquiries
3 Provide quality assurance management of change controls, discrepancies, deviations, failures, and non-conformance; assures timely investigations and use of CAPA (corrective action/preventative action) system
4 Establish and facilitate site tracking, trending, and continuous quality improvement programs
5 Develop direct QA reports and work closely with them to ensure that a consistent approach is taken in evaluation and resolution of quality issues
6 Support QA audits to qualify suppliers and third party vendors for contractual manufacturing, testing, and packaging
7 Approve protocols, reports and other GMP documents for the Quality Assurance department
8 Collaborate effectively with site operational management to support company and site business objectives.  Manage QA department resources so that business objectives are cooperatively supported without sacrificing product quality principles

Reporting to this Position:
QA Manager, Sr. Quality Analyst, Quality Auditor, Quality Assurance Compliance Specialist and other QA positions as applicable.

Travel:
Position may require 10% travel

Work Shift:
This position typically works days, but is responsible for supporting production across multiple shifts


Knowledge, Skills and Abilities:
  • Demonstrated ability to understand complex quality issues and drive scientifically sound and compliant resolutions
  • Excellent oral and written communication skills
  • Expert knowledge of cGMPs and FDA pharmaceutical regulations
  • Well-developed interpersonal and problem solving skills
  • Excellent leadership and organizational skills
  • Ability to effectively interpret and analyze data so that decisions can be made on product quality
  • Ability to effectively interact with the following internal and external contacts/customers:
    • Other site departments to address quality and cGMP compliance issues, as well as to implement site and business programs
    • Aprecia Pharmaceuticals corporate groups (GMP Compliance & Quality Systems, Purchasing, Regulatory Affairs, Quality Operations, Quality Control, R&D, and Manufacturing) to address cGMP compliance and outside contractor issues
    • Contractors, suppliers, and outside packagers to resolve quality issues
    • Regulatory agencies on site compliance matters
Education and Experience:
  • B.S. degree in a scientific discipline (e.g. chemistry, biology, microbiology, chemical engineering), or equivalent combination of education and experience
  • Minimum of ten (10) years of experience in any role in the pharmaceutical industry
  • Minimum of five (5) years of experience in QA management role
  • 1-3 years supervisory experience required
  • Prior experience within pharmaceutical QA in an operations environment 
  • Prior experience in implementing and integrating a QA system is desired
  • Prior experience hosting visit from regulatory agencies
Physical Demands and Work Environment:    
  • Sitting at a desk for extended periods of time
  • Standing and walking for extended periods of time
  • Occasional lifting of boxes (5-10 pounds) containing documentation
  • Speaking and listening abilities to communicate with employees and external parties
  • Bending, kneeling, and other odd body positions while accessing files and performing other job duties
  • Manual dexterity to operate a computer for extended periods of time
  • Good eyesight to create, read, and interpret business documents
  • Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (i.e. respirators, over-gowning, gloves, steel toe shoes)


GENERAL INFORMATION:
The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies.  The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position.  It is not intended to be an exhaustive list of all duties, responsibilities, and skills required.  The position may require other duties as assigned and can be changed at any time by the company.


We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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