Roche · 6 hours ago
Principal Quality Systems Specialist, Developmental Science
South San Francisco
Full-time
Onsite
Lead/Staff
$132K/yr - $245K/yr
12+ years expRoche is a leading company in the pharmaceutical industry, and they are seeking a Principal Quality Systems Specialist to provide quality and compliance leadership within Developmental Science. The role involves developing quality objectives, maintaining compliance with regulations, and leading cross-functional initiatives to enhance quality systems.
BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
Responsibilities
Developing partnerships with key enterprise business partners and stakeholders to advance compliance solutions and enable transparency, escalation, and resolution of quality and compliance matters
Seeking ways of continuously improving and uses sophisticated analytical thought to exercise judgement and identify innovative solutions in Quality and business processes
Developing Quality Objectives, Metrics, and Quality planning/strategic initiatives for QSC and DevSci
Independently leading and/or participating, in intradepartmental, global and cross-functional initiatives, working groups and project teams as a decision maker or as a lead reviewer of complex initiatives and solutions
Partnering with and/or leads global and cross-functional teams in the development, review, implementation of Global GLP, GCP/GVP, US HCO, pHCO policies and procedures and DevSci business instructions and guidance
Maintaining the highest level of expertise in GLP, GCP, and laws & regulations, industry best practices, and internal policies and procedures impacting drug development to promote quality and compliance within DevSci. Embeds quality principles throughout the organization
Identifying trends in quality events and collaborates with management and stakeholders to ensure risk-based solutions are implemented in a timely manner
Participating in internal/external audits and inspections as requested
Identifying potential compliance matters and drives the development and implementation of methods for improvement and resolution in a pragmatic and effective manner. Supports QMS activities including self-reporting of deviations, root cause analysis and CAPA plan development and evaluation
Leading and/or participateing in the following Quality/Compliance Teams and is expected to provide regular updates on the team’s projects/initiatives to management: DevSci-TM Quality and Compliance Committee (DTQCC), GLP Archives Management Team (GAMT), DevSci-TM Training Team (DT3), gRED Risk Management Team (gRMT)
Responsible for the oversight and governance of DevSci QMS processes and staff related to Change Control, CAPAs, Deviation Management, Document Management, GLP Archival, Records Management, Risk Management, Service Provider/Vendor Management, and Training Coordination/Management
Performs any other tasks as requested by management to support quality oversight activities
Develop and deliver compliance training to DevSci functions based upon identified needs
May coach colleagues and help others develop expertise/ skills. May provide guidance and manage work activities of other staff members for specific projects or objectives
Qualification
Required
Bachelor's degree required (life science or other relevant healthcare discipline is preferred). Minimum of 12 - 15 Years; 10 - 13 Years with Masters; 7 - 10 Years with PhD/JD; 3 - 5 Years with MD experience in pharmaceutical drug development, preferably in regulatory compliance and/or quality responsibilities within a drug development organization
Strong understanding of quality assurance and regulatory compliance principles (GLP, GCP, GDP, Data Integrity, FDA, ISO)
Specialized depth and/or breadth of expertise in Quality Systems management and associated processes (Change Control, CAPA, Deviation, Document and Risk Management, Vendor Oversight, and Training)
Strong project management, analytical, organizational, and planning skills. Knowledgeable in stakeholder management and influencing change. Proven interpersonal skills, customer focused approach and effective teamwork and collaboration skills
Strong negotiation skills - can effectively drive discussions and decisions toward desired end-results
Performs work with minimal supervision. Exercises considerable latitude in determining objectives and approaches to assignments
Demonstrates strong verbal and written communication skills. Highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications
Strong process-orientation, has proven effectiveness in identifying, developing and implementing scalable/sustainable processes and other continuous improvements to achieve organizational efficiencies and increase effectiveness
Thinks innovatively for solutions. Applies creative problem solving and appropriate business solutions to effectively address compliance risk. Experience with cross-functional problem solving and driving change through to successful implementation
Detail-oriented with strong time management skills
Expert proficiency with Google Suite and Microsoft Suite
Good knowledge of data analytics and data visualization
Occasional domestic/international business travel may be required depending upon ongoing business activities
Company
Roche
Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.
10001+ employees
H1B Sponsorship
Roche has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$7.79BKey Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M
Leadership Team
Alan Hippe
Member of the Executive Board - Group CFO
Christine Bakan
Global Head and Group Vice President, Computational Science and Informatics R&D
Recent News
2026-01-25
2026-01-23
2026-01-22
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