Associate Director, QA Lot Release, Regulatory Affairs, and Document Control

Job ID: req3547
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis).

The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

KEY ROLES/RESPONSIBILITIES

• Oversee the development, implementation and maintenance of quality assurance systems and activities.
• Oversee generation and review of documents used in good manufacturing practices.
• Prepare manufacturing documentation for updated filing.
• Coordinates interdepartmental activities.
• May lead investigations and resolve potential product quality issues to improve efficiency.
• Select, develop and evaluate personnel to ensure the efficient operation of the function.
• Manage at least fourteen (14) QA/RA staff (2 direct reports and 12 sub reports), assigning tasks and ensuring workload is distributed evenly across the groups.
• Conduct employee performance reviews and approve employee leave and timesheets.
• Interact with senior management and client, as needed.
• Provide reports to QA management and the client as required.
• Oversee document revisions for process improvements.
• Review and approve change controls and deviations.
• Lead and facilitate special project initiatives associated with lot release, document control, and regulatory affairs.
• Manage all regulatory activities for new and mature products to ensure alignment and compliance with FDA and company policies.
• Manage the generation /compilation of technical CMC content sections, including narrative text /data tables and relevant reports, for Module 3 (+ labels for M1) of US-FDA Investigational New Drug (IND) Applications, Drug Master files or amendments.
• Manage the preparation of CMC-based responses to questions from US-FDA which may arise from IND submissions or associated amendments.
• Work with cross-functional teams to ensure timelines for CMC-related tasks are met.
• Disseminate CMC-related information and/or documents to collaborators/licensees, as needed on request by the client.
• Assist team by providing regulatory guidance to contractors and staff.
• Oversee and submit to the client for approval regulatory documents supporting clinical trials.
• Oversee clinical trial material and CFR reserves.
• Oversee investigations of product complaints.
• Review internal and Contract Manufacturing Organization (CMO) documentation including, but not limited to, batch records, testing records, deviations, and change controls.
• Oversee the release of incoming raw materials and components, and final drug products for Phase I/II client-directed clinical trials.
• Oversees document control activities including, but not limited to, routing documents for review and approval and issuing documents in support of GMP activities.
• Participate in Material Review Board meetings and meetings to support QA/RA activities.

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a scientific related field or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, must have 8 years' experience including 6 years as a manager.
• Must possess basic Microsoft Office skills.
• Must be able to obtain and maintain a security clearance.
• Experience in regulatory submission preparation in accordance with eCTD format, ICH, and US requirements.
• Experience with technical writing or compiling of the CMC section of INDs for vaccines and biologics.
• Experience with releasing incoming raw materials and components, and final drug products for Phase I/II clinical trials.
• Background in a functional discipline related to vaccine and biologics CMC is a plus (cell banking, upstream or downstream operations, validation, analytical testing, etc.).
• Working knowledge of FDA and international biologics/drug regulations.
• Working knowledge of regulatory initiatives including ICH, USP and other regulatory intelligence sources.
• Previous experience in GCP, GLP, or GMP regulated environment is desired.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration: Preferred Qualification

• Combination of QA, RA, and QC or manufacturing experience.
• Working knowledge of quality systems and regulatory CMC compilation.
• Experience with the GMP manufacturing of Phase I/II clinical material.

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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