Role Description: - Play a client facing Compliance Lead role in projects, programs, and support work.
- Provide consulting and guidance on quality and compliance needs to IT project teams and enable them to achieve compliance using a risk-based right-sizing approach.
- Take ownership of assigned project/program/support responsibilities and deliver to committed timelines.
- Meet quality expectations as per defined contractual obligations to the client.
- Monitor, guide and drive off-site teams to achieve defined milestones and key objectives.
- Always ensure external and internal process compliance of the team
Essential Skills: - Minimum of 5 years' experience as a Computer System Validation Consultant in a regulated environment (preferably Pharma) and must have played a lead role (able to work independently with minimal guidance).
- Worked in a Pharmaceutical company as QA/QC within the Sales and Marketing and/or Medical/Regulatory business.
- Good understanding of industry regulations (FDA and other regulatory agencies world-wide)
- Excellent communication skills with strong command over written and spoken English.
- Technical Writing experience and expertise with relevant tools (MS Office Suite, Adobe documentation Suite)
Desirable Skills: - Risk Management, Supplier evaluation and assessment and auditing experience is highly desirable.
- Experience of working in virtual teams across different cultures and geographies
- Experience of working with cloud-based technologies is desired
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.