Quality & Compliance Manager, Computer System Validation
Role Overview
The Quality & Compliance Manager, Computer System Validation manages the quality oversight and lifecycle validation of GxP computerized systems supporting CRO and laboratory operations.
The role partners with Quality, IT, system owners, operational teams, and external providers to ensure systems are fit for intended use, maintain data integrity, and remain compliant and inspection-ready from implementation through retirement.
The Manager establishes consistent, risk-based computer system assurance practices and drives continuous improvement across clinical and laboratory environments.
Key Skills for This Role
Full Job Posting
EDUCATION AND EXPERIENCE
- Bachelor’s degree in life sciences, computer science, information systems, engineering, healthcare, or another relevant scientific or technical discipline.
- A minimum of six years of progressively responsible experience in Quality Assurance, computer system validation, computer software assurance, information technology quality, or related discipline within a regulated life sciences environment.
- Demonstrated experience providing independent QA oversight of GxP computerized systems throughout the system lifecycle, including initial risk assessment, validation planning, requirements, testing, traceability, release, change control, periodic review, incident management, data migration, and system retirement.
- Experience reviewing and approving computer system validation or assurance documentation, such as validation plans, system risk assessments, requirements specifications, test plans and evidence, requirements traceability matrices, deviations, validation summary reports, and change-control records.
- Working knowledge of applicable regulatory requirements and industry expectations, including FDA electronic-record and electronic-signature requirements, EU Annex 11, ICH Good Clinical Practice, Good Laboratory Practice, and data-integrity principles.
- Experience supporting computerized systems used in CRO, clinical research, or laboratory operations, such as electronic data capture, clinical trial management, electronic trial master file, interactive response technology, laboratory information management, electronic laboratory notebook, chromatography data, quality management, and other GxP-regulated platforms.
- Experience with risk-based validation and assurance approaches for configurable commercial software, software-as-a-service solutions, hosted platforms, system interfaces, laboratory instrument software, and internally configured or developed solutions.
- Experience supporting supplier qualification, system or vendor audits, sponsor audits, regulatory inspections, and the assessment and remediation of computerized-system compliance observations.
- Demonstrated experience working collaboratively with system owners, Information Technology, Information Security, Clinical Operations, Laboratory Operations, Quality Assurance, vendors, and other stakeholders in a matrixed and geographically dispersed organization.
- Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.
- Preferred Education and Experience:
- Master’s degree in life sciences, computer science, information systems, engineering, quality management, regulatory affairs, or related discipline.
- Experience working within a contract research organization, regulated laboratory, biotechnology, pharmaceutical, or medical-device organization.
- Experience providing QA oversight across multiple GxP environments, particularly GCP, GLP, GCLP, and GMP.
- Experience managing or developing a geographically dispersed or global validation and quality team.
- Experience with laboratory platforms and instrument software, including LIMS, ELN, CDS, data-acquisition systems, interfaces, and automated laboratory workflows.
- Experience with clinical platforms, including EDC, CTMS, eTMF, IRT/RTSM, eCOA/ePRO, safety databases, and related data integrations.
- Experience with Agile, Waterfall, or hybrid system-development methodologies and the application of risk-based quality controls within the system development lifecycle.
- Experience hosting or supporting health-authority inspections and sponsor audits involving computerized systems, electronic records, data integrity, or system validation.
- Relevant professional certification, such as ASQ Certified Quality Auditor, ASQ Certified Manager of Quality/Organizational Excellence, ISACA Certified Information Systems Auditor, or an equivalent quality, auditing, or computer-system validation credential.
- Familiarity with current Good Automated Manufacturing Practice guidance and risk-based computer software assurance principles.
- Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$91,500—$120,000 USD
- Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
- Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
- If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
- Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [email protected] so we can investigate and take appropriate action.
- Candidates must be legally authorized to work in the country of employment without employer sponsorship.
- Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.
- This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs.
- The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.
- At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.
Preferred Qualifications
- This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$91,500—$120,000 USD
About Precision for Medicine
Global precision medicine clinical research organization integrating laboratory expertise, trial operations, and data intelligence for biotech and pharmaceutical sponsors.
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