Product Quality Director (COVID-19) - Military HIV Research Program

Join the HJF Team!

HJF is seeking a Product Quality Director to support theMilitary HIV Research Program (MHRP)located at Walter Reed Army Institute of Research (WRAIR)in Silver Spring, MD. HJF provides scientific, technical, and programmatic support services to MHRP.

The Vaccine Development and Production (VDP) Team of the WRAIR U.S. Military HIV Research Program (MHRP) and WRAIR Emerging Infectious Disease Program (EIDB) at the Henry M. Jackson Foundation (HJF) is recruiting for an Product Quality Leader - Biological Vaccines to be located onsite in Silver Spring and Bethesda, MD. The incumbent in this position will be accountable for the development and delivery of the quality and regulatory strategies for the lifecycle of the assigned Biological product/program in partnership with the Product Development, Clinical, Regulatory Compliance colleagues across the organization and key business partners. Utilizes strategic thinking along with technical expertise to influence product/program strategies that are aligned with the quality strategies. Leads the creation of an integrated quality plan, leveraging existing processes, governances and programs as applicable. PQL reviews/approves GMP documentation in lieu of Product Manufacturing and Sponsor organizations where required. The position supervises a team of quality control research associates and quality compliance officers and reports to MHRP and EIDB Sr. Leadership.

Responsibilities:
  1. Ensure that systems and procedures are in compliance with 21 CFR Parts 210, 211, 610, and ICH Q10 Pharmaceutical Quality System and that all raw materials, intermediates and final vaccine products are produced, tested and released by or under the supervision of MHRP-EIDB/VDP are in compliance with SOPs, cGMP, internal policies and procedures, FDA and EU regulations as applicable.
  2. Establish and maintain a GMP inventory management program to ensure that raw materials, intermediate and or final drug products meet the receipt, holding, manufacture, testing and disruption requirements for the geographical area.
  3. Oversee the establishment of all systems, procedures and specifications affecting product quality (e.g. batch records, SOPs and validation protocols).
  4. Ensure MHRP quality policy is understood, implemented and maintained at all levels of the organization and that systems, resources and action plans are reviewed and decisions made to attain sustainable compliance.
  5. Determine dispositions of drug substance, drug substance intermediates, drug product and packaged/labeled products according to established standards for clinical trials.
  6. Provide oversight of Stability Program management via oversight of activities conducted by Analytical and Technical Operations departments.
  7. Provide in-depth technical advice to advise teams regarding Phase I-III manufacturing, analytical and process development.
  8. Assist in the development, review, and approval of documents (i.e., IBs, Products Specs, Pre-IND, IND, IMPD, DSUR, and Annual Reports) governed by in-house and external Quality Systems.
  9. Perform review and determination of the appropriate course of action and potential impact on quality of all atypical incidents or observations related to the manufacture, processing, packaging, testing and holding of a drug product.
  10. Investigate and coordinate with contract manufacturers on all product quality complaints, their follow up and maintenance of applicable documentation.
  11. Inform regulatory agencies and sponsors of substandard drug product, manages batch rejection and recall decisions in conjunction with Sponsor(s) and MHRP leadership.
  12. Prepare and manage the VDP budget, evaluates new equipment and other capital expenditures and submits purchase recommendations.
  13. Ensure effective systems are used for qualifying, maintaining and calibrating critical equipment. Manage the disposition of validation/qualification documentation, including review and approval of validation/qualification protocols and reports.
  14. Establish and administer formal change control process, reviews and approves change control documents.
  15. Maintain control of GMP documentation (i.e. SOPs, protocols, test methods, stability protocols, executed BRs and master specifications etc.): protection and tracking of originals and managing the limitation and control of official copies.
  16. Provide controlled documents for preparation and amendment of CMC section of INDs and assist with responses to Regulatory Agency CMC comments.
  17. Approve and close investigations including OOS investigations.
  18. Implement and maintain a CAPA system including final approval of all CAPAs.
  19. Manage the internal audit program to assure conformation with cGMP and related regulatory requirements.
  20. Develop, negotiate and maintain Quality Agreements between MHRP-EIDB/VDP and vendors/contractors that provide services in analytical testing and drug product manufacturing.
  21. Audit and approve contract manufacturers, packagers, component suppliers or service providers through a vendor qualification system.
  22. Serve as primary contact between MHRP-EIDB/VDP and auditing authority during regulatory and sponsor inspections.
  23. Establish and maintain a GMP training program that identifies training requirements, training documentation and training comprehension. Ensure training is carried out and appropriately documented.

Required Knowledge, Skills and Abilities:
  1. Strong scientific & technical capabilities required.
  2. Experience in more than one quality related discipline is preferred, including but not limited to, product development operations, regulatory filing, clinical studies, manufacturing operations and clinical distribution.
  3. Experience in Biologics/Large Molecule Product Development is required.
  4. Experience in a successful leadership role in building, inspiring and managing a large global team and influencing stakeholders across a matrixed organization structure preferred.
  5. Well-developed leadership skills, executive presence and the ability to influence others in a matrix environment required.
  6. Excellent communication and organization skills required.
  7. Solid presentation, written and oral communication skills as well as the ability to meet deadlines required.
  8. Strong attention to detail and analytical / problem-solving skills required.
  9. Business oriented, independent and driven required.
  10. Self-motivated with high integrity and a pioneering spirit required.
  11. Pro-active, creative, open, forward and strategic thinker capable of operational execution required.
  12. Strong conceptual and analytical orientation, as well as creative and unstructured problem-solving skills.
  13. Able to evaluate problems and concepts from different perspectives; use data to identify key issues and opportunities and recommend sound and logical solutions.
  14. Strong results and customer focus orientation.

Minimum Education:Bachelor's degree in a scientific discipline required; Advanced degree is preferred.

Minimum Experience/ Training Requirements:Minimum 10 years of experience in drug development, quality, compliance or regulatory affairs in a regulated healthcare industry required.

Work Environment:Up to ~20% national and/or international travel as business needs arise. A few telework days are an option.

Background/Security: Eligibility to obtain and maintain a Tier I investigation/Public Trust and a Common Access Card (CAC).

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

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