WuXi AppTec

Director, GCP Quality Assurance

Job Locations US-TX-Austin
Job ID
2020-7108

Overview

WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a global Contract Research Organization (CRO) providing a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioequivalence), for products including pharmaceuticals, biologics, and medical devices. With expertise spanning all major therapeutic areas, we deliver the unique blend of an experienced team, combined with the creativity, responsiveness, and customer centric-focus of a highly nimble organization. This forward-thinking approach has allowed us to work on a variety of projects ranging from first-in-human products to marketed drugs and devices.

 

Founded in 2000, the WuXi AppTec is the leading global pharmaceutical, medical device open-access capability and technology platform company with more than 25,000 employees across 25 locations globally. The WuXi platform is enabling more than 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi AppTec’s dream that “every drug can be made and every disease can be treated.”

 

Responsibilities

The Director, GCP Quality Assurance (QA) oversees quality assurance functions for the company including, but not limited to development and maintenance of quality assurance programs and policies, oversight of inspections and audits, management of the Standard Operating Procedures (SOPs), and performing quality checks for deliverables as needed.  Can be remote-based, but preference is to be office-based at Austin, TX office site. 

 

Essential Job Functions:

  • Provides operational support for WuXi Clinical QA, NA-EU
  • Develop, implement, and maintain a GCP/ICH compliant quality assurance program
  • Maintain Standard Operating Procedures (SOPs) including periodic review and coordination of the initiation/revision of procedures and policies to ensure compliance with new/revised regulations and guidelines
  • Lead and/or assist with vendor audits.
  • Perform internal process audits.
  • Assist with management of contract auditors.
  • Provide regulatory guidance and interpretation to internal customers and external clients
  • Serve as focal point for sponsor or regulatory audits as required
  • Utilize metrics and other tools to monitor compliance and ensure continuous improvement of quality program
  • Provide direction and guidance to address compliance risks and keep senior management apprised of compliance risks
  • Perform quality checks for deliverables as needed
  • Partner with cross functional groups to resolve compliance issues and oversee the implementation of corrective and preventive actions
  • Position requires employee to be aware of budget constraints for the company and ensure activities performed within the operations unit are within the constraints of the budget
  • May be required to supervise and provide guidance to QA staff from other WuXi Clinical US facilities.
  • Gives direct supervision to independent quality assurance auditors engaged by the company to perform quality assurance functions
  • Must show ability to problem solve with consideration given to quality, time, and financial resources
  • Expected to require minimal supervision on operational decisions that can have substantial impact on infrastructure or company policies
  • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required
  • Ability to work in a team environment and independently as required
  • May be required to work weekends at times
  • Contributes to the overall operations and to the achievement of departmental goals
  • Thorough understanding of FDA Guidelines, ICH Guidelines, GCP, NDA, IND and other applicable regulations
  • Other duties as assigned

Qualifications

Experience / Education:         

  • Bachelor’s degree required; Master’s degree preferred. Education Degree focus in a life sciences discipline preferred.
  • At least 10 years’ experience in the Pharmaceutical/CRO Industry in a clinical quality assurance and clinical operations role (combination of both with majority of time spent in clinical QA).
  • Strong experience and knowledge of Good Clinical Practices (GCP) and ICH is required.
  • Extensive GCP audting experience required.  
  • Strong presentation skills
  • Demonstrated ability to provide leadership for key strategic issues and significant QA policies, practices and processes
  • Demonstrated experience in making decisions to resolve the most complex problems and in providing sound compliance advice and direction
  • Must have high level of attention to detail and must have ability to deal professionally with team members, clients and investigational sites
  • Must have knowledge of sponsor requirements for quality assurance functions within the CRO environment
  • Willingness to travel 20% is required; currently remote auditing is in place until COVID-19 restrictions are lifted.
  • Must exhibit positive, professional demeanor in all communications and must be able to introduce differing communication strategies to solve issues at the team and sponsor level
  • Must exhibit excellent technical writing skills and exceptional verbal skills in English and must show ability to be an active listener
  • Must have people management skills including ability to hire, counsel, and terminate employees; must also be able to create career plans and to monitor progress

 

Knowledge / Skills / Abilities: 

  • Must be fluent in English, both verbally and in writing, in a clear, understandable manner.
  • Ability to effectively communicate issues and to autonomously implement resolutions to team members
  • Must show excellent interpersonal communication skills and exhibit ability to lead a team using appropriate motivational skills, conflict management, and integrity
  • Must have excellent organizational skills and negotiation skills;
  • Must have project management skills including client management, fiscal management, and quality management; strong time management skills; and ability to thrive in stressful environment with multiple priorities

 

Physical Requirements:

  • Must be able to work in an office environment, which has minimal noise conditions
  • Ability to stand or sit for most of the work day
  • Must be able to perform some activities with repetitive motion, such as keyboarding

 

 

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.

 

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.

 

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