Principal Quality Systems Specialist, Developmental Science

Roche•South San Francisco, CA

About The Position

We advance science so that we all have more time with the people we love. The Quality Systems and Compliance (QSC) group provides compliance oversight for Development Sciences (DevSci)) in gRED. In addition, QSC is accountable for the implementation, realization and maintenance of Quality systems that support the Quality Management System (QMS) in DevSci, including business and quality process ownership of Change Control, Corrective / Preventive Actions (CAPAs), Deviations, Document management, Good Laboratory Practices (GLP) Archival, Records Management, Risk Management, Knowledge Management, Training Management and the Service Provider/Vendor oversight program. This position participates in and provides quality and compliance leadership in the design, establishment and maintenance of programs and processes that ensure quality products and services, in compliance with US and International quality systems regulations for GLP-regulated services and other applicable requirements. The Opportunity: As an integral member of our dynamic team, you will be: 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. Note: If not assigned as the primary owner of the aforementioned responsibilities, will serve as the backup and is familiar with the process/responsibilities for each role 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.

Requirements

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.

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. Note: If not assigned as the primary owner of the aforementioned responsibilities, will serve as the backup and is familiar with the process/responsibilities for each role
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.