[Hiring] Manager, Global Quality Systems & LIMS @Curia

Role Description

This role will effectively collaborate with cross-functional technical and operational teams across the sites and global functions to support the implementation and maintenance of the Global Quality Management System for GxP elements of the business, with primary focus on the Laboratory Information Management System (LIMS). The role includes the implementation of electronic systems that align with ICH Q10 and all applicable regulatory guidance. Strong technical and leadership experience, in a functional and cross-functional matrix, are critical to the successful execution of the roles and responsibilities of this role. Travel required as necessary.

Responsibilities

• Lead/partner with Site QC Operations, IT and CSV on the implementation and validation of electronic solutions (primarily LIMS, but also including Quality, Document, Learning, and other electronic Management Systems) in alignment with the Global Quality strategy.
• User training: provide support and training on LIMS and play a key role during hyper care implementation period.
• Partner with lab subject matter experts to gather business requirements and map existing workflows to system capabilities.
• Own and update LIMS Standard Operating Procedures (Global Process Owner for LIMS).
• Verify the effectiveness of Quality Systems through audits of Deviation/CAPA/CR reviews.
• Lead continuous improvement of Quality Systems, such as CAPA, Deviation, Investigation, and Change Management, and direct the efforts to develop, implement, and maintain compliant and effective Quality Systems.
• Responsible for developing various training programs by collaborating with the global compliance team and site teams.
• Help develop framework for and participate in new site implementation of global quality systems, and routine review/upgrade of these systems.
• 10-15% travel.
• Other duties may be assigned.

Qualifications

• B.S./B.A. or M.S. degree in Chemistry, Microbiology, or related field.
• Minimum of 5-7 years QC experience in the pharmaceutical or biotechnology industry.
• Experience in Quality Systems, with LIMS experience is a must. LabVantage experience is preferred.
• Experience in QC operations as a supervisor or manager in commercial GMP QC labs.
• Hands-on experience with developing, implementing, validating, and managing electronic systems (e.g., LIMS, QMS).
• Demonstrated leadership experience, both functional and cross-functional (e.g., project management, cross-functional teams, etc.).
• Strong knowledge of regulatory requirements (21 CFR Parts 11, 210, 211, 820).
• Strong change management/implementation experience.
• Minimum 2 years of managing quality laboratory systems (LIMS, ELN) in a global, multi-site environment.
• Excellent communication, time management, and organizational skills.
• Experience working in a high-level collaborative environment and promoting a teamwork mentality.

Knowledge, Skills and Abilities

• Strong analytical and problem solving abilities.
• Effective communication and interpersonal skills.
• Ability to work in a fast paced, regulated environment.
• Proactive mindset with the ability to anticipate and troubleshoot issues.
• Exceptional analytical thinking, strong attention to detail, and excellent verbal/written communication skills to bridge technical and scientific teams.

Other Qualifications

• Must pass a background check.
• Must pass a drug screen.
• May be required to pass Occupational Health Screening.

Benefits

• Generous benefit options (eligible first day of employment).
• Paid training, vacation and holidays (vacation accrual begins on first day of employment).
• Career advancement opportunities.
• Education reimbursement.
• 401K program with matching contributions.
• Learning platform.
• And more!