Compliance Manager, Quality Assurance

Additional Job Description

Home Based, US

The Quality Assurance (QA) Compliance Manager has a high level of knowledge and experience of appropriate GxP compliance and other applicable regulations and laws, Parexel procedures and appropriate Parexel processes to conduct audits and provide expert advice to internal and external clients. To effectively lead, matrix manages, develop, and implement assigned projects. To 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.

Expertise in Investigator Site Audits and Trial Master File Audits is mandatory, preferably with CRO experience.

Key Accountabilities:

• Management/coordination/oversight of QA compliance GxP activities in a specific geographical and/or functional/specialist area, as assigned by QA Sen Management
• Work closely with Regulatory authorities and Sponsors. Support regulatory inspections & sponsor audits as needed
• Act as QA Lead for billable audit programs or a client account for which QA representation is needed
• Maintain knowledge of project /audit status in assigned areas
• Support Third Party Supplier activities as needed
• Process Improvements
• Provide Trainings
• Build and maintain relationships
• Perform other quality related task or projects as assigned.
• Travel internationally on assignments as required. Travel time could be up to approx. 60%.

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
• Excellent knowledge of, and working experience with, relevant national / international regulations
• Lead team / project to successful conclusion
• Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups
• Work professionally with highly confidential information
• Work independently and consistently in a fast-paced environment

Knowledge and Experience:

• Preferred 5-8 years’ experience in Quality Assurance, regulatory affairs, auditing, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area such as technology, third party supplier management, including profound applicable GxP auditing.

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