Quality Assurance Manager

Quality Assurance Manager
Company:

(Confidential)


Quality Assurance Manager

Details of the offer

Objectives:
Provide QA support for Bridgewater, NJ Laboratory from project inception through successful filing. The role includes working with multidisciplinary teams to ensure pharmaceutical development activities are planned and executed in compliance with GMP standards and Vertice policies and procedures. Provide local quality assurance support to R&D organization.
Key Responsibilities:
· Ensure project plans adequately address GMP and Quality departmental requirements and standards. Work with functional departments to ensure plans are executed compliantly.
· Facilitate GMP Quality activities at Bridgewater site to ensure timely and compliant delivery of product and data. Assure GMP standards and Vertice?s policies are met.
· Review/approve GMP documents to ensure clinical material meets compliance expectations.
· Facilitate GMP product readiness and launch activities, including stability strategy, technology transfer and validation.
· Develop and implement systems to support the delivery of GMP projects. Work with analytical team during FDA related questions and lead FDA site inspection activities in Bridgewater, NJ.
· Supports site teams responsible for designing, implementing, and monitoring the CMC Quality System supporting the development of Drug Products including FDA inspection.
· Single Point of Contact for Quality in support of GMP specific work related to Bridgewater site.
Support method validations and GMP testing (analytical) from analytical labs

Support method transfer activities to client sites

Review and approve documentation in support of GMP testing

Approval of documents protocols and final reports for cleaning and method validations.

· Modify, enhance, and develop SOPs to continuously improve how site work is conducted in a GMP facility.
· Develop and track GMP Metrics / measuring systems and work with management to implement corrective actions in response to negative trends.
· Manage the Stability Program:
· Develop strategy for developing stability and method performance monitoring programs for products.
Perform Root Cause Analysis, working with analytical team when stability issues are found and develop an action plan for successful resolution
Requirements & Qualifications:
· Bachelor?s degree BS in scientific discipline (Chemistry, Biology, Microbiology or related field), graduate degree a plus.
· Fluent knowledge of Pharmaceutical GMP regulations and guidelines.
· Analytical Method development (desired, not required).
· Statistical analysis, Minitab knowledge a plus.
· 5-10 years in of relevant Pharmaceutical Quality experience, supporting R&D and/or Analytical Laboratory.
· Strong computer skills
· Strong relationship building skills
· Excellent communication (verbal and written) skills
· Experience working in a changing environment and fast-paced organization as a member of cross-functional teams (Quality, R&D and Regulatory Affairs) a must.
· Experience in Project Management a plus.
Light travel might be required to another site in Largo, Florida.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
Equal Opportunities
As an equal opportunity employer, Vertice Pharma is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. It is also Vertice's policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.
Job Type: Full-time
Additional Compensation:
Bonuses

Benefits:
Health insurance
Dental insurance
Vision insurance
Paid time off


Source: Jobsxl


Area:

  • Other Jobs / Other Jobs - Crafts

Requirements

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