Job Summary:

This Senior Compliance Consultant job description reflects the responsibilities and expertise needed to manage our customers compliance at a strategic level in highly regulated areas compliance, manage risk, computerized system validation (CSV) activities, data integrity, regulatory audits and support quality systems.

Skills:

• Strong decision-making abilities, with a proven ability to guide cross-functional teams through complex compliance initiatives.
• Excellent problem-solving skills, with a deep understanding of root cause analysis and risk management methodologies.
• High attention to detail and ability to maintain compliance with GxP standards across diverse functional areas (manufacturing, clinical, lab, etc.).
• Superior written and verbal communication skills, with the ability to clearly convey complex regulatory requirements to stakeholders at all levels.
• Ethical mindset and commitment to patient safety and product quality.
• Ability to build and maintain strong relationships with clients and understand their business needs.
• Collaborative and able to work well in a team environment.

Key Qualifications:

• Experience in Microsoft Office Suite, particularly Excel, word and PowerPoint.
• Certification Desired and 1 year of experience in Project Management and process modelling application/ tool.
• Proficiency in GxP compliance software systems (e.g., Veeva Vault, TrackWise, MasterControl) and strong knowledge of electronic record management.
• Proficiency in electronic systems for ALM, such as KNEAT, HPQC, VALGENEIS.
• Experience with FDA 21 CFR Parts 11, 210, 211, ICH guidelines, EU GMP, ISO 13485, ISPE, and other international GxP regulations.
• Proven track record of leading regulatory audits and inspections, with demonstrated success in managing complex compliance initiatives.
• Experience with managing global compliance programs and interacting with regulatory bodies across multiple regions (e.g., FDA, EMA, MHRA).
• Certification in GAMP5, CSV, ISO is desired, or equivalent is highly desirable.

Experience (in years):

• 5-9 years of experience in regulatory compliance, quality assurance, validation or a similar role within a GxP-regulated environment.

Academic Qualification:

• Bachelor’s degree in life sciences, pharmacy, biotechnology, IT, engineering, or a related field.
• A PhD or advanced degree in a related discipline is preferred.

Language(s):

• English (Technical) ,Any European language ( German, Spanish, Danish etc)