Sr. Clinical Quality Associate

Primary Job Function

Responsible for supporting Global Clinical Affairs personnel globally in ensuring compliance with medical device and GCP regulations and standards, as well as company policies and procedures and other applicable requirements.

Core Job Responsibilities

• Responsible for compliance with applicable regulations and standards, as well as Corporate and Divisional Policies and procedures.
• Study Support
  • Review study documents for compliance to applicable regulations, standards, and internal procedures
• Support compliant execution of clinical research projects
• Preferably has prior experience with GCP regulations and standards, including 21 CFR Parts 50, 54, 56, 812 and ISO 14155 CAPA
• Generate CAPA documentation, including investigations, resolution plans, and implementation reports
• Ensure work complies with regulatory and compliance standards
• Work cross-functionally to develop pragmatic and compliant solutions for CAPA activities
• Drives continuous process improvement
• Strong written communication skills

Audits

• Internal/External Audits
  • Key player in the preparation and overall support for internal and external audits, including responding to audit findings such as through the CAPA process
  • May perform internal compliance assessments and/or audits
  • Support project teams in preparation for regulatory authority inspection or audit, or corporate or divisional regulatory compliance audit
  • May support other clinical quality tasks as requested and as need arises.

Position Accountability / Scope

• Job/Technical Knowledge : Strong understanding of Good Clinical Practice (GCP) including U.S. regulations and international standards, Quality Assurance/Control, as well as of relevant regulations and procedures
• Cohoperation/Teamwork : team player with autonomy capable of working independently under minimal supervision
• Planning and organizational skills : organizes self in an efficient manner
• Problem solving : gathers information before making decisions; weighs alternatives against objectives and arrives at reasonable decisions
• Adaptability : remains open-minded; performs a wide variety of tasks and changes focus quickly as demands change
• Initiative / Innovation : explores alternative successful ways of working and tools; able to challenge conventional practices; creates novel solutions to problems

Education and Experience

• Required Qualifications : Bachelors Degree (± 16 years), In related field OR an equivalent combination of education and work experience Minimum 4 years, Related work experience with a solid understanding of specified functional area. Broad knowledge and application of business concepts, procedures and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Learns to use professional concepts and company policies and procedures to solve routine problems. Works on problems of limited scope. Independent decision making required.
• Preferred Qualifications : Prefer at least 5 years of medical devices, clinical research experience, or related industry. Prefer at least 3 years of related work experience in Quality role in medical device area and/or clinical trial environment. Prefer GCP audit experience.