Manager, Principal Compliance Engineer

About the role

Challenging. Meaningful. Life-changing. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

Responsibilities

• Ensure Equipment Compliance
• Review and implement revisions to USP, EP, JP, FDA, and regulatory guidelines
• Perform gap analyses on existing equipment and technologies
• Review new equipment and technologies to ensure compliance
• Ensure ECQ Departmental Compliance
• Participate in revisions of departmental procedures to maintain compliance
• Ensure departmental procedures and policies are aligned with current local, global, and regulatory requirements
• Historical Performance Review (HPR) and Compliance Project Support or lead HPR on-demand board meetings and investigations/deviations
• Identify, scope, lead, and support projects of varying complexity to maintain equipment and departmental compliance
• Regulatory Responsibilities
• Participate in and prepare for both internal and external audits

Requirements

• Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements, and good documentation practices
• Advanced understanding of pharmaceutical, manufacturing, and laboratory systems and equipment
• Strong attention to detail
• Exceptional written and verbal communication skills
• Excellent interpersonal skills; experience working with a diverse workforce
• Prioritization and organizational skills; ability to manage multiple concurrent assignments in a high-paced environment
• Strong presentation development and delivery skills
• Highly proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Extensive background in database systems
• Ability to quickly learn new software, such as corporate intranet and enterprise business applications
• Ability to organize and present information clearly

Qualifications

• BS in Engineering or Science-related discipline is required
• Minimum of 5 years’ experience in an FDA-regulated industry
• 2 years’ experience in a quality assurance-related discipline preferred
• In-depth knowledge of regulatory guidelines (FDA, EMA, USP, EP, JP)
• Excellent computer skills, including knowledge of calibration management and environmental monitoring systems
• Strong verbal and written communication skills; able to work independently
• Must possess strong interpersonal and communication skills, be a team player, and demonstrate professional maturity, initiative, and accountability