Head of Quality and Regulatory Affairs

Job title:

Head of Quality and Regulatory Affairs

Company:

Sasmar

Job description

SASMAR is currently seeking a highly skilled and experienced individual to join our team as the Head of Quality and Regulatory Affairs. With our headquarters based in Brussels, Belgium, and operations in Sydney, Hong Kong, Mumbai, Malta, London, and Chicago, we are a fast-growing pharmaceutical company that specializes in personal care and fertility products, including our renowned Conceive Plus brand. Our products are distributed in over 70 countries through various channels such as supermarkets, clinics, hospitals, pharmacies, and drugstores.As the Head of Quality and Regulatory Affairs at SASMAR, you will be responsible for providing leadership and strategic direction to our Quality Assurance and Regulatory Affairs teams. This role involves ensuring compliance with global regulatory requirements, overseeing quality control processes, and driving continuous improvement initiatives to maintain the highest level of quality and safety across our products.At SASMAR, we foster a diverse and inclusive work environment. We believe in equal opportunities and offer a supportive atmosphere for personal and professional growth.Responsibilities

• Develop and execute quality assurance strategies, policies, and procedures to ensure compliance with global regulatory requirements.
• Oversee the management of product quality and safety, including risk management processes.
• Collaborate with cross-functional teams to drive continuous improvement initiatives and implement best practices.
• Ensure timely and accurate submission of regulatory documents and compliance with regulatory standards.
• Monitor and analyze industry trends, changes in regulations, and emerging issues related to quality and regulatory affairs.
• Manage relationships with regulatory authorities and participate in regulatory inspections and audits.
• Review and approve quality and regulatory documentation, including protocols, reports, and standard operating procedures.
• Provide guidance on regulatory requirements and industry standards for new product development and existing product enhancements.

Requirements

• Bachelor’s degree in a relevant scientific field, such as Pharmacy, Chemistry, or Biology. Advanced degree is preferred.
• Extensive experience in Quality Assurance and Regulatory Affairs within the pharmaceutical or medical device industry.
• Strong knowledge of global regulatory requirements, including FDA, EMA, and other relevant agencies.
• Proven leadership and people management abilities.
• Excellent understanding of quality management systems, including ISO 13485 and other relevant standards.
• Thorough knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Exceptional analytical and problem-solving skills.
• Excellent communication and interpersonal abilities.
• Ability to work in a fast-paced and dynamic environment.
• Experience in managing regulatory inspections and audits.
• Relevant certifications in quality management and regulatory affairs are highly desired.

Benefits

• Competitive salary
• English language and multi-cultural work environment
• Private Health Insurance (medical, dental, hospitalisation)
• Paid Time Off
• Work From Home / hybrid
• Career advancement opportunities in stable company
• Modern offices, convenient to public transport.

Expected salary

Location

Bruxelles

Job date

Mon, 12 Aug 2024 22:01:06 GMT

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