Job Overview:
We are looking for a Compliance Officer to join our team. In this role, you will ensure that the company adheres to all relevant pharmaceutical regulations, by developing and implementing compliance policies, conducting audits, and maintaining vendor contracts. You will serve as the primary contact for client compliance concerns, collaborating to ensure seamless onboarding and project alignment with regulatory requirements. Additionally, the role involves monitoring quality metrics, providing staff training, and driving continuous improvement initiatives across the organization
Key Responsibilities:
- Ensure the company complies with all relevant local, national, and international regulations, including FDA, EMA, and other pharmaceutical regulatory bodies.
- Stay up to date with changing pharmaceutical laws, guidelines, and industry standards.
- Develop and implement compliance policies and procedures that align with these regulations.
- Collaborates with functional departments to resolve issues and maintain compliance
- Serve as point of contact for compliance-related issues with clients, addressing their concerns and ensuring their projects comply with all regulations.
- Collaborate with clients to ensure smooth onboarding processes and align their needs with internal compliance protocols.
- Identifying gaps in systems and developing feasible plans for correction
- Training of personnel on quality systems processes
- Monitoring and trending metrics
- Preparation and review of Standard Operating Procedures, Non-conformances, CAPAs etc.
- Preparation and maintenance of technical agreements and any other relevant agreements.
- Oversee vendor compliance to ensure they meet the company's and clients' regulatory standards.
- Conduct due diligence and regular audits on vendors to assess compliance with pharmaceutical regulations.
- Develop and maintain vendor contracts that include compliance requirements, ensuring proper documentation and communication channels.
- Participates in continuous improvement initiatives
- Any other duties assigned by X.
This role requires a proactive approach to maintaining regulatory standards, managing relationships with both clients and vendors, and ensuring that compliance is at the core of all business operations.
Competencies:
- Excellent organizational abilities, personal efficiency, and time management, with a strong capacity to prioritize competing demands.
- Skilled in building relationships and fostering collaboration with others.
- Effective in strategic decision-making, serving as an influential voice within the business.
- Proven ability to prioritize critical initiatives, drive business growth, and establish KPIs for performance monitoring.
- Positive, proactive, and motivated by taking on significant responsibilities.
- Practical and action-oriented approach to managing teams and priorities.
- Proficient in software tools.
Requirements:
- Bachelor’s degree in a Science related discipline
- Desirable a minimum of 3 years experiences of working in a similar role in the pharmaceutical industry
- Knowledge of EU quality related pharmaceutical regulations.
What We Offer:
- Competitive salary and benefits
- Opportunity for growth and development
- Flexibility working conditions
