- Provide quality oversight throughout development program at Aquestive, including but not limited to: pre-clinical trials, early and late phase development clinical trials, post-marketing clinical trials, investigational product.
- Work cross-functionally with stakeholders across the business to support the escalation and management of Events/Deviations, Corrective and Preventative Actions (CAPAs), Root Cause Analysis (RCA), as well as ad hoc issues impacting business processes.
- Assist in managing core clinical and quality processes, including ownership of some QMS processes, as applicable.
- Serve as the GLP/GCP subject matter expert to cross-functional clinical trial teams to ensure that all quality and regulatory compliance activities were conducted in compliance with GCPs, SOPs and ICH Guidelines.
- Assist in establishing processes to ensure Data Integrity and communicate the principles of data integrity for GLP/GCP.
- Interpret regulations, as appropriate for the phase of development, applying and/or adapting to internal policies and procedures.
- Manage Audit Readiness Program (routine, and Pre-Approval Inspection), with ability to act as lead host for an agency inspection.
- Partners with the Clinical Operations and Clinical Development in the qualification process of new vendors, or new services to be utilized from existing vendors, and assesses the associated risk, potential audit requirements; plans, schedules and conducts necessary audits or manages 3rd party for audit conduct.
- Completes clinical investigator site audits to assess adherence to the Study Protocol and associated documents, applicable regulations, guidance/guidelines.
- Completes preclinical laboratory inspections as directed by study protocol.
- Assist in review/approval of other development program GxP documentation, such as: Master Batch Records, Specifications, Test Methods, Protocols, Reports, SOPs.
- Assist in review and release clinical trial supply (investigational product) for use in human clinical trials; issuance of Certificate of Analysis/Conformance.
- Act as internal auditor within Aquestive's established Quality Management System.
- Analyze, report and present metrics where applicable to show health of system(s).
- Other duties as assigned.
- Bachelor's degree required; scientific field (chemistry, biology) or professional medical required (MD, PharmD, RN, etc.).
- 5+ years of QA experience in a GCP setting for any phases of clinical trials in biotech or pharma required.
- Experience auditing GCP vendors who provide clinical trial and nonclinical study services, internal GCP processes and documents, and clinical investigator sites preferred.
- Experience in managerial role, with or without direct reports, required.
- Must have experience collaborating with other teams such as Regulatory Affairs, Clinical Development, Quality Assurance, Legal, Clinical Operations, etc.
- Excellent knowledge of GCP (GLP, GPvP and GMP are an advantage).
- Demonstrated ability to apply quality-based decision making to a problem.
- Ability to take ownership of, organize and prioritize workload and projects on time.
- Excellent oral and written communication.
- Ability to work independently under strict timelines.
- Travel required 25% (international and domestic)
- Must be located within 40 miles of Warren, NJ office and have ability to be in office minimum of 2-days a week
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Manager, GCP Quality Assurance - Warren, United States - Aquestive Therapeutics
Description
Job Summary:
This position is responsible for providing robust quality oversight throughout Aquestive's development program. The successful candidate will provide quality expertise to manage and improve processes across Aquestive's development program, ensuring compliance with Good Clinical Practices (GCP), Good Laboratory Practice (GLP), Preclinical stage and GMP for clinical manufacturing oversight. The ideal candidate will leverage his/her experience, understanding of regulations, and interpersonal skills, to proactively contribute to quality oversight activities.
Responsibilities:
Qualifications:
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.
Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
