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- This section contains a list of the major responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.
- Oversee Vendors and Supporting partners related to communications, issues resolutions, expectations, and timelines.
- Initiate and investigate Product Complaints, Quality events, deviations and CAPAs in the electronic Quality Management System (eQMS) and ensure timely resolution by working cross-functionally and with contract facilities to review and approve.
- Participate and/or lead recurrent and ad-hoc meetings with contract facilities for the assigned clinical and commercial products, representing the QA function.
- Conduct QA review of executed manufacturing and packaging batch records. Work with the contract facilities to resolve all issues before Batch or material disposition. Perform Batch Release.
- Perform vendor qualification, routine and for cause audits. Issue audit report, review, and approve audit response and track action items/CAPAs to closure. Documents all audit activities using the Vault eQMS.
- Assist with hosting Partner audits and regulatory inspections.
- Compile, analyze, and present key performance metrics in preparation for Management Review meetings.
- Maintain Vendors performance dashboards and conduct Vendors risk management activities.
- Create, review, and approve quality documents such as Policies and Procedures.
- Execute other projects as required to meet department and company objectives.
- Conduct Annual product Review related activities.
- Review and draft Vendors Quality agreements.
- Initiate, review, and approve Change controls. Perform QA impact assessments and identify change actions related to the proposed change. Work with contract organizations and/or internal departments to ensure timely completion of change controls.
- Review and approve validation protocols, stability protocols and summary reports and other Quality operations related records.
- Participate in preparation of regulatory submission documents/filings.
- Strives to maintain a safe working environment through the prevention of accidents, the preservation of equipment, and the achievement of safe working practices.
- Maintains a positive and professional demeanor toward all vendors, customers, partners and coworkers.
- Adhere to all policies and procedures of TerSera Therapeutics.
- Performs other duties as assigned.
- Strong experience in the Quality Management System elements (e.g., Change Control, Deviation, Complaints, Supplier Qualification, Document Control etc.).
- Strong experience with solid dosage, aseptic fill finish manufacturing and combination products batch review and release.
- Solid understanding and application of FDA 21 CFR 4, 11, 210 & 211, and the EU Guidelines for Good Manufacturing Practice Medicinal Products for Human and Veterinary Use.
- Experience in identifying stakeholders and working cross-functionally to resolve quality issues.
- Analytical thinking, problem solving and negotiation skills.
- High level of flexibility and willingness to change priorities as quality issues arise.
- Excellent organizational skills, strong oral and written communication skills, and ability to work in a high paced, timeline driven corporate office setting.
- Minimum: Bachelor's degree, preferably in a Life Science or Engineering discipline.
- Required: Must have a minimum of eight (8) years of experience in quality assurance in the pharmaceutical industry.
- Required: Experience interfacing with and managing outsourced cGxP activities.
- Preferred, but not required: Auditor certification (ASQ or other certifying body) or auditor experience.
- Preferred, but not required: Experience with the Veeva Vault QualityDocs and eQMS suites or similar Quality management systems.
Senior Quality Assurance Manager - Deerfield, United States - TerSera Therapeutics
Description
Job Type
Full-time
Description
Summary:
TerSera Therapeutics is a small, privately held specialty pharmaceutical company with an aggressive growth history in the pharmaceutical sector. Our continued growth has created an exceptional opportunity for a full-time Senior Quality Assurance Manager.
The Sr. Quality Assurance Manager reports to the VP, Quality Assurance and is responsible for managing assigned quality management systems and Quality Operations related activities within TerSera Therapeutics LLC (TerSera).
The individual oversees TerSera GxP Vendors, contracted facilities and is the subject matter expert on the quality requirements for assigned products.
Essential Duties and Responsibilities:
Standard non-essential functions for all TerSera Therapeutics employees.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.