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Senior Director, Quality Assurance

Company: WuXi AppTec Inc
Location: Saint Paul
Posted on: August 6, 2022

Job Description:

Overview:
Responsible for developing, implementing and representing the quality assurance programs as well as recommending measures to ensure the fulfillment of management quality objectives. - - - - - -

Responsibilities:
Drives the GLP/cGMP principles and international laboratory quality standards to laboratory areas.Ensures regulatory trends are monitored and communicated to all laboratory areas.Assures adequate QA support and oversight for all regulated areas and other selected laboratories to ensure adherence to high quality standards and compliance with all applicable regulatory requirement, in particular GLP/cGMP compliance.Review/Approve site operation and QA SOPs.Maintain active dialog, close communication and working relationship with all levels of laboratory personnel, TFM and line management on purpose, direction and goals of quality management.Assures conformance with authorized policies and procedures. Directs improvements, development, and implementation of Quality Assurance (QA) programs and procedures. Assures consistency with other WuXi AppTec sites.Oversees quality auditing program and GLP/cGMP practices. Assures health authority inspections and accreditation/certifications are fully supported and ensure appropriate and consistent inspection practices.Participates in the review and development of Client Quality Agreements.Provides direction for consistency in quality assurance operations and regulatory interpretations.Directs development and presentation of compliant training program for GLP/cGMP and assures employees receive appropriate training.Assures suppliers are assessed for compliance to applicable quality and regulatory requirementsDirects operations of the QA Department. Directs the review of new technology, methods, and equipment with respect to QA.Makes appropriate recommendations for correction and improvement when necessary. Conducts employee performance appraisals in a timely and objective manner.Recommends hire/promotion/discharge and salary changes and acts on employee problems.Contributes to the overall operations and to the achievement of departmental goals.Other duties as assigned.

Qualifications:
Experience / Education - - - Bachelor degree in scientific discipline.Education and experience to meet applicable regulatory requirements.At least of 10 years of Quality Assurance experience in GLP-regulated environment.At least 5 years of experience successfully leading/managing a QA function including direct people management responsibility.Experience in software documentation, software development life-cycle management and 21 CFR Part 11 compliance.Demonstrated experience directing the overall management of Quality Assurance programs.Preferred experience: Working knowledge of 21 CFR parts 11, 58, 820, ISO 17025 and/or ISO 13485, standards. Additional knowledge of 21 CFR parts 210/211, 610, 1270/1271, OECD GLP and AATB standards is a plus.Professional certifications, such as Certified Quality Improvement Associate (CQIA), Lead Auditor. Knowledge / Skills / Abilities:Demonstrated functional leadership skills in a regulated environment.Proficient verbal & written communication skills.Able to read, write and understand English.Proficient in Microsoft (Excel, Word, Outlook, Visio).Ability to function and lead in a matrixed, team environment and independently as required.Demonstrated knowledge of national and international regulations pertaining to medical devices, biopharmaceutical, and aseptic processes.Thorough understanding of Good Laboratory Practices (21 CFR Part 58) and ISO standards.Knowledge of Quality Management System software.Travel is required as needed to company or client sites.Physical Requirements:Ability to stand / sit / walk for long periods of time Must be able to perform activities with repetitive motionsMust be able to work in lab setting with exposure to biohazards / chemicalsMust be able to wear appropriate PPE as necessary -An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability - - - -This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. - Employees holding this position will be required to perform any other job-related duties as requested by Management.

Keywords: WuXi AppTec Inc, St. Paul , Senior Director, Quality Assurance, Executive , Saint Paul, Minnesota

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