- QA Manager
- NY, NY - Remote Possibility
An up-and-coming clinical stage Biotech Company focused on treating individuals with rare neurological disorders is seeking a QA Manager to join their rapidly expanding team! Their pipeline consists of 10 different indications 7 of which are in the early stages of clinical trials. If you are looking for an opportunity in QA that will allow you to have an impact on the organization as a whole.
The QA Manager will have the following responsibilities:
- The incumbent will have the responsibility for day-to-day Quality Assurance oversight and management of compliance operations for the company with a concentration on on-going Pre-Approval- Inspections activity for API and Drug Products. Responsibilities include, but are not limited to, the following: a) Manage the Pre-Approval Inspection efforts for API and drug products to include drafting, review and/or approval policies, procedures, work instructions, plans, etc., related to API and DP; b) Review and approval of any change request associated with the policies, procedures, work instructions, plans, etc; and 3) Provide training on associated documents supporting PAI's where required.
- Establish PAI plan to includes identification of documentation needed to support the approval efforts, establish timelines for completion and delegate where required.
- Coordinate PAI efforts with Associate Director, Regulatory, QA and CMC to ensure all areas required are covered under the plan.
- Provide periodic updates to management (Associate Director, Regulatory, QA and CMC) on the "plans" progression. Using metric evaluation, track the progression versus goal completion date.
- Communicate with Regulatory Agencies on issues that may arise during the PAI preparation period and post approval at the request of the Associate Director, Regulatory, QA and CMC.
- Maintain specifications through the Document Management System for in-process testing and finished product testing of DP and API, raw materials, starting materials and packaging components. Revise as necessary and report changes to regulatory agencies as required.
- Provide support for Annual Review / Annual Product Review as required.
- Represent Quality Assurance and Regulatory, as required, to assure that internal departments are informed and aware of issues related to PAI and other critical areas identified by the Associate Director, Regulatory, QA and CMC.
- Manage projects and prioritize team efforts to accomplish successful end result. Provide any risk assessment for issues and evaluate impact to the organization.
- Provide support for Batch Record Review as required.
- As needed/required, lead or support Client/Partner audits or Regulatory Inspections.
- Provide leadership on teams involved with the day-to-day management of OVID's Quality Operations and Systems.
The ideal candidate will have the following skill set:
- Bachelor's Degree or equivalent skills or work experience.
- A minimum of 10 years' preferred experience in the pharmaceutical industry with related experience in Quality Assurance, Quality Control and Manufacturing.
- A minimum of 5 years supervisory, management or leadership role in the pharmaceutical industry.
- Experience working in domestic and international biopharmaceutical regulatory audits / regulatory inspections environments.