2 Manager of Quality Systems and Compliance Jobs in Rochester, NY
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Manager of Quality Systems and Compliance
$107k-137k (estimate)
Full Time | Securities
2 Weeks Ago
Vaccinex is Hiring a Manager of Quality Systems and Compliance Near Rochester, NY
Position Title: Manager of Quality Systems and Compliance
Classification: Exempt
Salary Range: $90,000-$150,000
Reports to: SVP Clinical Development
Effective Date:
Job Summary:
The Manager, Quality Systems and Compliance is responsible for identifying, coordinating, and executing tasks related to the effective organizational and tactical management of the Quality Systems function at Vaccinex. This individual is responsible for helping Vaccinex achieve and maintain compliance with cGMP, GLP, and GCP (i.e., GXP) requirements through activities such as: planning and scheduling appropriate training for Vaccinex personnel; planning, scheduling, and conducting both internal audits and external vendor/supplier audits designed to assure the high quality of these systems; managing and contributing to unplanned and planned events, Change Control, CAPA, and laboratory investigations; updating and/or assisting in the preparation of standard operating procedures; and assisting in the review and revision of the quality elements of regulatory submissions. The position is a “hands-on” position that involves not only the identification of various tasks but also participation in the execution of these tasks.
Essential Functions /Responsibilities
- Manages the Quality Systems function and staff, and assists in creating and maintaining a regulatory compliant cGMP environment at Vaccinex.
- Manages the release of bulk drug substances, reference standard material, unlabeled drug products, placebo and label, and packaging label copy for drug product and placebo.
- Leads/conducts internal and supplier audits for GXP compliance.
- Participates in lot-release and stability data review and in the development and establishment of specifications.
- Prepares and/or assists in the preparation of policies, standard operating procedures, work instructions and forms appropriate to the cGMP environment.
- Provides ongoing employee training in the requirements for operating in a GXP environment.
- Participates in the review of the quality elements of regulatory submissions.
- Travel to contract organization and supplier sites as necessary to ensure operational readiness and quality assurance in the manufacture of Vaccinex investigational products.
Qualifications & Competency
- Excellent verbal and written communication skills.
- Excellent interpersonal and customer service skills.
- Excellent organizational skills and attention to detail.
- Excellent time management skills with a proven ability to meet deadlines.
- Strong analytical and problem-solving skills.
- Strong supervisory and leadership skills. Ability to prioritize tasks and to delegate them when appropriate.
- Ability to function well in a high-paced and at times stressful environment.
- Proficient with Microsoft Office Suite or related software.
Supervisory Responsibilities
- Recruits, interviews, hires, and trains new staff.
- Oversees the daily workflow of the department.
- Provides constructive and timely performance evaluations.
- Handles discipline and termination of employees in accordance with company policy.
Physical Requirements
Examples:
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times.
Position type and Expected Hours:
- Full time with a floating 40 hours per week schedule Monday-Friday
Travel
- This position is remote / hybrid, with some travel required.
Education and Experience
- B.S./B.A. degree or higher in biological or physical sciences.
- Eight (8) or more years in the bio/pharmaceutical industry, including at least 6 years of progressive experience in Quality Systems associated with the manufacture, testing and release of biologic drugs.
Additional eligibility Qualifications
- Demonstrated scientific expertise related to the manufacture, laboratory testing, and release of therapeutic biologic products (e.g., therapeutic monoclonal antibodies,) in the bio/pharmaceutical industry.
- Demonstrated experience in the management of the quality and compliance elements of biologics manufacturing activities, applying an intimate knowledge of FDA cGMP and GLP regulations to the manufacture, laboratory testing, and release and testing of biologic drug substances and drug products.
- Demonstrated experience in the preparation for and the conduct of audits of suppliers providing GXP-compliant services related to the manufacture, testing and release of biologic drugs (e.g., Certified ISO XXX Lead Auditor).
Work Environment
Remote / Office
Affirmative Action / EEO
- This job profile is intended to provide an overview of expected job duties and requirements. It is not intended to be a contract of employment, explicit or implicit. All contents are subject to change at the sole discretion of the company. Other duties may be assigned as needed.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Securities
SALARY
$107k-137k (estimate)
POST DATE
05/18/2024
EXPIRATION DATE
07/16/2024
WEBSITE
vaccinex.com
HEADQUARTERS
ROCHESTER, NY
SIZE
500 - 1,000
FOUNDED
2001
TYPE
Public
CEO
JAMES VILLA
REVENUE
<$5M
INDUSTRY
Securities
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About Vaccinex
Vaccinex is a biotechnology company that develops and commercializes therapeutics for the treatment of cancer and neurodegenerative diseases.
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