Manager, Global Quality Systems & LIMS

Curia; Oregon; Hybrid; USD 119,000 - 150,000; Full time

Benefits offered by this job

Generous benefit options

Paid training, vacation and holidays

Career advancement opportunities

Education reimbursement

401K program with matching

Learning platform

And more!

Job summary

Curia Aalborg ApS is seeking a Manager, Global Quality Systems and LIMS to lead implementation and validation of electronic systems (LIMS and related) in support of the Global Quality strategy. The role requires collaboration across sites and functions, training users, and maintaining SOPs.

Travel 10-15% and strong leadership in a regulated environment are essential. Remote in Eastern or Central Time, with global coordination and regulatory knowledge.

Qualifications

• Minimum 5–7 years QC experience in pharmaceutical or biotech industry.
• Experience in Quality Systems with LIMS; LabVantage experience preferred.
• Experience in QC operations as a supervisor or manager in GMP labs.
• Hands-on experience developing, implementing, validating, and managing electronic systems (LIMS, QMS).
• Demonstrated leadership across functional and cross-functional teams (e.g., project management).
• Strong knowledge of regulatory requirements (21 CFR Parts 11, 210, 211, 820).
• Minimum 2 years managing quality laboratory systems (LIMS, ELN) in a global, multi-site environment.
• Excellent communication, time management, and organizational skills.
• Experience working in a fast-paced, regulated environment and promoting teamwork.

Responsibilities

• Lead/partner with Site QC Operations, IT and CSV on the implementation/validation of electronic solutions (primarily LIMS) in alignment with Global Quality strategy.
• Provide user training on LIMS and support during hyper care implementation.
• Collaborate with lab SMEs to gather requirements and map workflows to system capabilities.
• Own and update LIMS SOPs (Global Process Owner for LIMS).
• Verify effectiveness of Quality Systems through audits of Deviation/CAPA/CR reviews.
• Lead continuous improvement of Quality Systems (CAPA, Deviation, Investigation, Change Management).
• Develop training programs with global compliance and site teams.
• Assist in new site implementation of global quality systems and routine review/upgrade.
• Travel 10-15%.
• Other duties may be assigned.

Skills

Quality Systems

LIMS

Leadership

Regulatory Knowledge

Project Management

Communication

GxP Compliance

Education

B.S./B.A. in Chemistry or Microbiology

M.S. in related field

Tools

LabVantage

ELN

QMS

Job description

Manager, Global Quality Systems and LIMS (Remote in Eastern or Central Time)

Build your future at Curia, where our work has the power to save lives.

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.

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life‑saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.

We proudly offer

• 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!

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

Salary range: $119,000-$150,200/year

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.