Job Description
Job Description
Altimmune (NASDAQ: ALT) is a clinical stage biopharmaceutical company focused on developing treatments for obesity and liver diseases. Our pipeline includes next generation peptide therapeutics for obesity, NASH (pemvidutide) and chronic hepatitis B (HepTcell). For more information, please visit www.altimmune.com.
Job Description:
The Supplier Quality Manager-Sr Manager is responsible for management of systems and processes supporting Altimmune's oversight of its GMP suppliers. The essential duties will be to manage the supplier change control system, oversee supplier investigations, support supplier validation activities, and manage combination product development activities. The selected candidate will have a detailed understanding of manufacturing processes, tech transfer, analytical testing, quality systems and GMP requirements for drug products and combination products. The candidate will promote a quality-oriented culture and will report to the VP, Quality and Compliance Management.
Essential Functions:
Oversee the change control system for Altimmune material and supplier-related changes.
Prepare and process change controls for changes submitted by supplier sites.
Initiate change controls for internal Altimmune changes to materials, systems, design history file documentation, etc.
Assess the impact of changes on systems, documentation, and product quality.
Facilitate change control reviews by functional area representatives and assemble change control review board meetings as needed.
Monitor the completion of change control action items and track changes to closure.
Support the investigation of supplier deviations and laboratory events through critical review of supplier investigation reports, ensuring thorough root cause analysis, impact analysis and identification of robust CAPAs to improve supplier processes.
Review and approve supplier deviations and investigations.
Investigate Altimmune internal deviations, perform root cause analysis, identify corrective and preventive actions (CAPAs), and monitor the effectiveness of CAPAs.
Manage product complaints and conduct product complaint investigations.
Serve as a QA lead on combination product development projects and oversee risk management activities.
Review and maintain design history file documentation.
Review and approve technical plans, protocols, and reports related to supplier process validation and analytical validation activities.
Support QA Operations in reviewing executed batch production records and testing documentation and in performing lot disposition activities to ensure compliance with approved procedures, quality agreements and GMP expectations.
Assist in the preparation, execution, reporting and follow-up of internal and external audits.
Author, review and revise site SOPs to ensure compliance with GMPs, regulatory requirements and corporate standards.
Assist in managing and maintaining Quality Assurance documentation.
Participate in quality system improvements.
Perform other duties as assigned by Quality Assurance Management.
Job Requirements (Essential knowledge, skills and attributes):
Bachelor's degree or higher in a technical or scientific discipline is required.
A minimum of 10 years of experience in a GMP-related industry with at least 7 years of experience in GMP quality assurance in the pharmaceutical or medical device industry.
Experience with both pharmaceuticals and medical devices is preferred.
Strong knowledge of 21 CFR Parts 4, 210, 211, and 820, as well as ICH and other drug product, medical device, and combination product standards and guidances.
Demonstrate a solid understanding of pharmaceutical and medical device manufacturing - process, analytical operations, quality systems, and regulations.
Ability to build strong collaborative relationships with partners within and outside of the organization.
Excellent communication and interpersonal skills for effectively interfacing with internal and external personnel at all levels.
Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment.
Excellent problem-solver with the ability to work independently.
Trained and experienced in performing root cause analysis investigations including CAPA planning and management.
Excellent organizational skills with the ability to prioritize assignments.
Excellent written and verbal communication skills.
Excellent attention to detail and commitment to high quality work.
Proficient use of MS PowerPoint, Excel, Word, Teams, and Adobe Acrobat.
Experience with Veeva Vault is a plus.
Experience performing quality audits is a plus.
Occasional travel up to 5-10% of time.
The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire or request a medical or religious accommodation.
Altimmune provides equal employment opportunities to all employees 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.
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