Prenetics, a leading genomics-driven health sciences company, is revolutionizing prevention, early detection, and treatment. Our prevention arm, CircleDNA, uses whole exome sequencing to offer the world's most comprehensive consumer DNA test. Insighta, our $200 million joint venture with renowned scientist Prof. Dennis Lo, underscores our unwavering commitment to saving lives through pioneering multi-cancer early detection technologies. Insighta plans to introduce Presight for lung and liver cancers in 2025, and to expand with Presight One for 10+ cancers in 2027. Lastly, ACT Genomics, our treatment unit, is the first Asia-based company to achieve FDA clearance for comprehensive genomic profiling of solid tumors via ACTOnco. Each of Prenetics' units synergistically enhances our global impact on health, truly embodying our commitment to 'enhancing life through science.
We are seeking an exceptional Senior Scientific Officer & Head of Compliance (Laboratory) to oversee and ensure compliance with regulatory standards, quality management systems, and best practices within our laboratory environment. The ideal candidate will have extensive knowledge of laboratory regulations, experience in implementing compliance programs, and a strong background in scientific research and analysis. As the Head of Compliance, you will play a critical role in maintaining the integrity of our laboratory operations and driving a culture of compliance.
Responsibilities:
- Develop and implement a comprehensive compliance program to ensure adherence to regulatory requirements, quality standards, and best practices within the laboratory.
- Serve as the primary point of contact for regulatory agencies and oversee all interactions, inspections, and audits related to laboratory compliance.
- Stay current with local, state, and federal regulations applicable to laboratory operations, including but not limited to safety, environmental, and data integrity requirements.
- Lead and manage a team of compliance professionals, providing guidance, training, and support to ensure a robust compliance culture throughout the laboratory.
- Establish and maintain laboratory quality management systems, including document control, change control, deviation management, and CAPA (Corrective and Preventive Action) processes.
- Develop and implement standard operating procedures (SOPs) and protocols to ensure consistent and compliant laboratory practices.
- Conduct regular internal audits and inspections to identify areas of non-compliance and develop corrective action plans to address any deficiencies.
- Collaborate with laboratory personnel to ensure proper training and understanding of compliance requirements, including safety protocols, data integrity, and good laboratory practices (GLP).
- Implement and maintain effective risk management processes to identify, assess, and mitigate compliance risks within the laboratory.
- Continuously monitor industry trends, regulatory updates, and emerging compliance issues to proactively address potential risks and implement necessary changes.
- Ph.D. in a scientific discipline (e.g., Chemistry, Biology, Biochemistry) or equivalent experience in a laboratory setting. Additional certifications in quality management and compliance are preferred.
- Minimum of 10 years of experience in laboratory operations, scientific research, and compliance management, with a focus on regulatory requirements and quality assurance.
- In-depth knowledge of laboratory regulations, including but not limited to FDA, EPA, OSHA, and relevant international standards (e.g., ISO 17025).
- Strong understanding of quality management systems, including document control, change control, deviation management, and CAPA processes.
- Proven experience in developing and implementing compliance programs within a laboratory environment, including risk assessments, SOP development, and training initiatives.
- Excellent leadership and management skills, with the ability to build and motivate a team, and foster a culture of compliance and continuous improvement.
- Strong analytical and problem-solving abilities, with a keen attention to detail and the ability to interpret and apply complex regulations and standards.
- Outstanding communication and interpersonal skills, with the ability to effectively interact with internal stakeholders, regulatory agencies, and auditors.
- Experience with laboratory accreditation processes (e.g., ISO 17025, GLP) and proficiency testing programs is highly desirable.
- Demonstrated commitment to ethical conduct, data integrity, and maintaining the highest standards of quality in laboratory operations.
Our DNA is P-R-E-N-E-T-I-C-S. See what each word of our company name means:
Get to know us; Get to know our DNA!
Passion
- You are passionate about our mission and your job, and inspire others with your drive for excellence.
Resilience
- You are tenacious and calm despite challenges, changes, and stress. Sleeves rolled up, you attack every challenge head-on.
Empowerment
- You help colleagues across Prenetics succeed. You foster a strong team spirit while encouraging others to take initiatives and risks.
Integrity
- You are trustworthy, honest and accountable to your actions and commitments.
Epic
- You dare to take risks, deliver results and make things happen. You possess a growth mind-set and strive to continuously improve.
Transparency
- You speak up and share information even if it is controversial or difficult.
- You share wins and failures openly.
Ingenuity
- You make wise decisions despite ambiguity.
- You think outside the box, challenge the status quo and come up with creative solutions.
Communication
- You practice empathy, articulate your thoughts and ideas effectively and respectfully.
Selfless
- You seek what is best for Prenetics, not yourself or your team. You put the needs of the team before your own.
