Sr. Compliance Specialist

Sr. Compliance Specialist

For its biotech partner, Kelly Life Science is looking for a:
Sr Compliance Specialist
Permanent position

Your mission:
You will be responsible for supporting client and internal audit programs, global risk management, management review, quality agreements and inspection readiness workstreams onsite. You will also implement change as required, to ensure compliance to cGMP requirements.

Your responsibilities:

• Support the internal audit programs on sites. Act as lead or support auditor, manage internal audit schedules
• Support and client audit programs onsite. Coordinate client audit responses and ensure adequacy and appropriate corrective actions. Host client audits
• Acting resource for execution of health authority inspections onsite. Assist with preparation of inspections and/or responses to observations. Support inspection readiness workstreams and remediation activities to ensure the site is always ready for inspection
• Support site management review by obtaining and compiling data for quality system performance and improvements
• Support management of quality agreements by ensuring they are current and facilitating conversations with internal stakeholders
• Work with colleagues internally and at other sites to ensure corporate compliance and implementation of corporate policies in site specific procedures

Your profile:

• Master's degree with more than 5 years' experience in a QA cGMP regulated environment in pharmaceutical or biotech industry
• Experience in auditing/inspection programs within regulated operations
• Experience managing and executing Quality Systems
• Additional experience in manufacturing, quality control, or technical operations within a regulated environment is required
• Fluent in French and English

Your contact at Kelly:
Mrs Cristina Alvarino
Consultant Professional Staffing Life Science
Kelly Life Sciences Geneva