CQV Risk-Based Approach Expert

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

Your Role

The Risk-Based Approach expert for CQV is responsible for developing and implementing risk-based strategies for the commissioning, qualification, and validation of systems, equipment, and processes in regulated industries such as pharmaceuticals and biotechnology. This role involves leveraging systematic risk assessments to allocate resources effectively, ensuring that high-risk areas receive the highest scrutiny and control.

We are hiring within the United States, in which short-term and long-term travel is required as needed for project assignments and client engagements.

• Develop and implement risk-based qualification approaches and strategies, including Failure Modes and Effects Analysis (FMEA), Risk Assessments, and Preliminary Hazard Analysis (PHA).
• Serve as a subject matter expert (SME) to support internal and external inspections, ensuring compliance with regulatory expectations.
• Conduct systematic risk assessments to determine the criticality of systems, processes, and equipment, focusing on maintaining product quality and patient safety.
• Collaborate with various departments, including engineering, quality assurance, and regulatory affairs, to align on risk-based CQV strategies and ensure seamless execution.
• Document CQV activities to demonstrate compliance and ensure traceability throughout the product lifecycle.
• Provide training and competency development for personnel involved in CQV activities to ensure the integrity of validation processes.
• Manage change control processes to maintain compliance with regulatory requirements while implementing changes to facilities, systems, equipment, and processes.
  
  

Requirements

• Extensive experience in CQV, with a strong focus on risk-based approaches.
• In-depth knowledge of regulatory guidelines and standards, including FDA Process Validation Guidance, EMA's Annex 15 on Qualification and Validation, and EU GMP Annex 20.
• Proven ability to develop and execute risk-based CQV strategies, ensuring compliance with regulatory expectations.
• Strong analytical and problem-solving skills, with the ability to conduct thorough risk assessments and develop effective mitigation strategies.
• Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.
• Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
  
  

Preferred Skills:

• Familiarity with industry best practices and standards, such as ASTM E2500 and ISPE’s Baseline Guide Vol. 5.
• Experience in managing capital project budgets and supporting site cost improvement initiatives.
• Ability to provide training and develop competency in CQV activities for team members.