Compliance Manager

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.

As a Technology Quality Assurance (TQA) Compliance Manager, you will be a subject matter expert (SME), holding significant authority and decision-making powers in clinical trials. You will autonomously conduct assessment of technology, data integrity practices, and regulatory compliance to ensure adherence to requirements. If deviations or non-compliance are identified, you will have the authority to recommend necessary changes and corrective actions. Additionally, you will engage with clients, investigators, and other stakeholders to address compliance issues and provide guidance on best practices. You will serve as an expert in the field, your decisions have a substantial impact on fostering a culture of compliance, quality, and continuous improvement.

You will play a vital role in conducting audits, providing expert advice, and leading process improvement initiatives to uphold GxP technology compliance. You will demonstrate flexibility and initiative, effectively managing and coordinating TQA compliance activities across regions, functions, and specialty areas. You may also act as TQA leads for audit programs or for clients. You will provide insight, leadership, and meticulous auditing processes promoting the high standards of quality, safety, and compliance in clinical research operations.

Accountabilities:

Management of QA compliance GxP activities:

• Lead and work independently and as part of the QA team

• Act as expert GxP technology consultant in relevant area to groups within the Parexel organization and Parexel clients.

• Promote compliance within the company and represent QA, as required.

• Review Parexel SOPs as assigned to ensure GxP compliance of processes

• Proactively re/review and oversee QA SOPs and be able to speak to their contents.

• For area of specialization, work with internal customers and develop and execute strategic audit plans for the area.

Work closely with Regulatory Authorities and Clients. Support regulatory inspections & client audits as needed

• Provide consultation and interpretation on regulatory compliance to internal/external clients, Parexel management, and staff with regards to the implementation of GxP technology requirements, and implementation of appropriate regulatory requirements.

• Act as a contact with members of Regulatory Authorities and / or clients; lead their audits / inspections in agreement with QA management.

• Act as key contributor for review of client audit/regulatory inspection findings.

• Provide strategic feedback and trending for Regulatory Inspectorates and client audits.

Act as QA Lead for billable audit programs or client account for which QA representation is needed

• Oversee billable audit programs.

• Create and maintain the Audit Process Plan (APP) for the program.

• Coordinate billable audits across all regions.

• Act as main QA contact for the client and the Parexel project teams

Lead and coordinate internal audits and audit programs (global and regional)

• Plan and conduct complex/for cause audits as assigned across all phases of Clinical Research including, but not limited to project related audits, system audits, supplier qualification and re-qualification audits in order to evaluate the quality system against the appropriate regulatory requirements, relevant procedures and applicable guidelines. Ensure required audits are performed and reported in accordance with Parexel QA requirements, and on time.

• Coordinate internal global process/system audits across regions and develop all necessary tools such as report templates, checklists and standard emails. Report outcome and trends of audit program to the process owner, QA Senior Management. Resolve program related issues in a constructive and pro-active way.

• Travel internationally for audits as required. Travel time could be up to approx. 25%.

Maintain QA Records / Systems

• Manage tasks or initiatives as assigned, including teams of multifunctional personnel, as needed.

• Maintain required QA tools and ensure Parexel and QA systems are regularly updated with accurate information for audits and other activities.

• Maintain and / or develop records / documents for assigned areas

Process Improvements

• Optimize new and existing processes to maintain and improve quality standards including supporting quality initiatives as assigned

• Assist QA Management in the development and implementation of audit plan, strategic procedures and working practices to ensure continuous quality improvement.

Provide Trainings and Mentoring

• Develop and present training courses as needed.

• Train new and existing less experienced QA personnel.

Build and maintain relationships

• Build, develop, and maintain good working relationships with internal and external customer groups.

• Work well in team environment.

Education:

• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience

• Master’s degree in a science, technology or industry related discipline, preferred.

​Skills:

• Ability to develop relationships with a culturally diverse group of key stakeholders within Parexel and the client’s business

• Excellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessions

• Experience with Microsoft based applications and ability to learn internal computer systems

• Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork

• Ability to work flexibly and adjust to changing priorities and unforeseen events

• Diplomatically address sensitive issues confidentially and professionally

• Strong planning, execution, and coordination skills

• Solid knowledge of, and working experience with, relevant national / international regulations

• Lead audits/audit programs to successful conclusion

• Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups

Knowledge and Experience:

• Strong experience in regulatory affairs, auditing, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area such as technology, third party supplier management.

• Advanced level experience and exposure in quality assurance, auditing, including sound experience of applicable GxP technology auditing

• Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research.

In return we will be able to offer you a structured career pathway and encouragement to develop within the role including awareness and understanding of the industry.  You will be well supported and for your hard work you will be rewarded with a competitive base salary as well as a benefits package including holiday and other benefits that you would expect with a top company in the CRO Industry.

Apply today to begin your Parexel journey!