Senior Technology Quality Assurance Auditor

Posted 2 Days Ago
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Hiring Remotely in North Carolina
Remote
Senior level
Pharmaceutical
The Role
As a Senior Technology Quality Auditor at Parexel, you will lead and coordinate technology audits, manage internal audit programs, and support regulatory inspections. Your role involves providing guidance on compliance and best practices, maintaining QA records, and building relationships with diverse stakeholders while ensuring adherence to industry standards.
Summary Generated by Built In

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Home Based, US

As a Senior Technology Quality Auditor (TQA) you will have the experience and knowledge to provide guidance and facilitate the effective preparation, management and follow up of internal and supplier technology audits. You will exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle confidential information diplomatically. The TQA Senior Auditor will play a crucial role in conducting audits that impact business operations, processes, and systems, contributing to meeting client needs and maintaining high compliance standards.

Technology Quality auditors possess significant authority and decision-making power within clinical trials. They autonomously assess technology, data integrity practices, and regulatory compliance, recommending necessary changes to ensure adherence to standards when deviations or non-compliance are identified. Technology Quality auditors also provide guidance on best practices and address compliance issues through discussions with sponsors, investigators, and stakeholders. The requirement is to be capable of traveling up to 60% of the time.

Accountabilities:

  • Lead, perform and report audits
  • Manage Technology audits
  • Lead and coordinate internal audit programs (global and regional)
  • Support Serious Breaches
  • Support Auditor Training and Mentoring
  • Maintain QA Records / Systems
  • Support Sponsor Audits and Regulatory Inspections
  • Maintain sound knowledge of Parexel policies, procedures, and guidelines and promote compliance within Parexel
  • Build, develop, and maintain working relationships with internal and external customer groups

Skills:

  • Excellent interpersonal, verbal and written communication skills
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
  • Experience with Microsoft based applications and ability to learn internal and supplier computer systems
  • Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork
  • Ability to develop relationships with culturally diverse stakeholders, including Parexel team members and sponsor representatives
  • Ability to work professionally with highly confidential information
  • Flexibility and ability to adjust to changing priorities and unforeseen events
  • Excellent time management skills and the ability to follow-up on multiple tasks and projects
  • Ability to diplomatically address sensitive issues confidentially and professionally
  • Ability to work consistently in a fast-paced environment

Knowledge and Experience:

  • Strong knowledge of GxP, industry standards, applicable international technology compliance regulations

  • Must be detail oriented and able to maintain a ‘big picture’ overview during a sponsor audit or inspection

  • Ability to follow up on multiple tasks and projects, and to handle confidential information diplomatically

  • Familiar in technology as it relates to clinical trial activities, including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems

Education:

  • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
  • Five to nine years of experience in Quality Assurance, auditing, relevant Quality Management and clinical trial support

EEO Disclaimer
Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Top Skills

Microsoft
The Company
HQ: Durham, North Carolina
20,524 Employees
On-site Workplace

What We Do

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.

Community Guidelines
Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are:

• Abusive, harassing or threatening to others.
• Defamatory, offensive, obscene, vulgar or depicting violence.
• Hateful targeting by race/ethnicity, age, color, creed, religion, gender,
sexual preference or orientation, nationality or political beliefs.
• Sexually explicit or pornographic.
• Fraudulent, deceptive, libelous, misleading or unlawful.
• Referencing criminal or illegal activity.
• Spamming.

We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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