We are seeking a highly skilled and motivated Commercial Qualified Person (QP) to join our client, a well-established, fast-growing pharmaceutical company. As a Commercial QP, you will play a critical role in ensuring compliance with regulatory and quality standards for commercial activities related to the distribution, sale, and marketing of pharmaceutical products. Your primary responsibility will be to oversee the release of products for commercial distribution and ensure their continued compliance throughout the product lifecycle.
- Serve as the designated Commercial Qualified Person (QP) for the company, responsible for ensuring compliance with all relevant regulatory requirements and guidelines.
- Oversee the release of pharmaceutical products for commercial distribution, ensuring that all necessary documentation and testing have been completed in accordance with applicable regulations and company standards.
- Review and approve commercial documentation, including batch records, labeling, packaging, and distribution records, to ensure accuracy, compliance, and alignment with regulatory requirements.
- Collaborate with cross-functional teams, including production, quality assurance, regulatory affairs, and marketing, to support commercial activities and resolve any quality-related issues.
- Conduct regular audits and inspections of commercial activities, including manufacturing facilities, warehouses, and distribution centers, to ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant quality standards.
- Act as a point of contact for regulatory authorities and participate in regulatory inspections, ensuring timely and appropriate responses to any findings or queries.
- Stay updated with evolving regulatory requirements, guidelines, and industry best practices, and proactively communicate changes to relevant stakeholders within the organization.
- Provide guidance and training to personnel involved in commercial activities to enhance understanding and compliance with regulatory requirements.
- Identify and implement continuous improvement initiatives to optimize commercial processes and enhance efficiency while maintaining compliance with regulatory standards.
- Bachelor's degree in pharmacy, pharmaceutical sciences, or a related field. Advanced degrees and certifications are a plus.
- Prior experience as a Qualified Person (QP) within the pharmaceutical industry, with a focus on commercial activities, is essential.
- In-depth knowledge of global regulatory requirements, including but not limited to EU GMP, FDA regulations, ICH guidelines, and other relevant industry standards.
- Strong understanding of commercial processes, including supply chain management, distribution, marketing, and sales activities within the pharmaceutical industry.
- Proven track record of successful regulatory inspections and audits.
- Strong problem-solving skills and the ability to drive continuous improvement initiatives.
- Familiarity with quality management systems, document control, and electronic systems used in the pharmaceutical industry.
If you are a highly skilled and motivated professional looking to contribute to the success of a dynamic pharmaceutical company, we encourage you to apply for the position. This position will offer a competitive salary, comprehensive benefits package, and opportunities for career growth and development within our organization.