Director, R&D Quality Inspection Management

Gilead

Cambridge, United Kingdom

POSITION OVERVIEW:

You will act as a primary point-of-contact for R&D Quality inspection management and act as an inspection readiness ambassador, supporting the drive to a continuous improvement company culture. You will lead development and maintenance of a comprehensive and connected framework for continually improving inspection management, supporting R&D personnel with the readiness, preparation, conduct and follow-up for GCP, GLP/GCLP and GPV inspections by regulatory health authorities. You will typically represent Gilead in regulatory inspections as a lead representative and point-of-contact for regulatory agencies. You will collaborate cross-functionally to ensure Gilead's ongoing regulatory compliance and R&D GxP quality operations in accordance with Gilead's Quality Management System (QMS) and related policies and procedures. You will play a role in development and maintenance of an intelligence change management system and framework. You will typically play a key role in developing the short- and long-range R&D inspections management strategy, infrastructure and resource plans. You may also support senior colleagues in R&D Quality Inspection Management. You may have one or more direct reports. You will also play a leadership role in special projects that advance the capabilities and/or resources of the overall R&D Quality Inspection Management group and/or the wider R&D Quality organization.

EXAMPLE RESPONSIBILITIES:

Responsible for the effective management, execution and oversight of R&D inspection activities and deliverables, including but not limited to, establishing standards and processes for defining inspection readiness, the preparation and conduct of inspections, the integration of lessons learned into preparation and the continuous scanning, assessment and implementation of regulatory changes.

Inspection Readiness, Preparation, Conduct & Close-out:

May serve as business process owner of inspection management in R&D;
Leads all designated operational, managerial and administrative activities within R&D Quality Inspection Management;
Supports global Gilead R&D inspection readiness, in partnership with the Quality Business Partners and functional area leads, by advising on Gilead practices, procedures, systems and other tools;
Collaborates and proactively engages cross-functionally to gather and analyze risks and establish mitigations, as well as support remediation where needed;
Develops and delivers inspection specific GxP training for assigned for the R&D organization (including playbooks and responsibility matrices);
Builds relationships and a network of cross-functional stakeholders to promote and enhance inspection readiness;
Contributes to generation and continuous improvement of Gilead R&D inspection preparation tools to support Inspection, leads, and SMEs;
Provides a framework to ensure training of Gilead R&D personnel on dossier collation and requirements pre-regulatory agency inspections, in partnership with the Inspection Lead;
Prepares and leads instructor led training of Gilead R&D personnel in preparation for regulatory agency inspections;
Leads and/or advises Subject Matter Experts on responses to regulatory agency inquiries and inspections, as necessary coordinating a united company response, in conjunction with the Inspection Leads and Inspection Sponsor(s);
Analyses, consolidates and integrates prior Gilead and external intelligence to shape Gilead R&D inspection readiness;
Coordinates inspection management horizon scanning, tracking and archiving activities;
Contributes to metric generation and analysis across inspections to identify and respond to emerging trends and potential risks and integrates into the Quality Management Review;
Drives for Veeva QMS record development on all inspection findings and action plans, including commitment follow-up and oversight.

GxP Regulatory Compliance, Intelligence & Change Management:

Supports development and execution of a compliance (GxP) intelligence change management program and operating framework;
Mines, analyzes, evaluates and escalates potential risks associated with emerging intelligence;
Evaluates SOPs, other procedures, data and reporting of assigned R&D groups/locations to ensure ongoing regulatory compliance, R&D quality and fit-for-purpose to both Gilead business needs and changing regulatory requirements;
Plays a role in preparing the assigned R&D groups / locations for changes to regulations or other requirements and associated continuous improvement initiatives;
Contributes to a GxP external engagement program and knowledge management hub to monitor and track Development’s engagement with external groups and conferences as well as encouraging and facilitating presentations and creating a collective voice for Gilead GxP compliance;
Serves as point of contact and R&D Quality voice on external consortiums or compliance working groups;
Leads and advises on continuous improvements to R&D inspection management processes, procedures, practices and tools.

Leadership:

Provides collaborative matrixed leadership to project and inspection teams;
Typically leads and manages direct reports. Where, applicable hires, develops and retains diverse top talent on the team. Sets clear and elevating goals for the team and individuals direct reports. Coaches direct reports on their performance, development and career interests;
Contributes to resourcing planning and budget, ensuring delivery against objectives and with good business judgement and priorities;
Ensures own work, and that of direct reports, complies with established practices, policies and processes, and any regulatory or other requirements;
Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D and with R&D vendors.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Education & Experience:

BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry, including significant experience working in quality, compliance or a related field;
Significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and continuous improvement;
Significant experience in inspection management in the biopharma industry;
Proven track record of effective people leadership and management, as evidenced through past effectiveness with employee engagement, development and retention either with direct reports or through matrix leadership responsibilities;
Line management (direct reports) experience preferred;
Track record of cultivating and maintaining strategic relationships and collaborations both internally and externally;
Experience participating or leading external consortiums, trade associations, professional bodies or industry groups;
Proven track record of successfully managing large scale, complex, time-sensitive projects;
Hands on experience leading cross-functional process improvement initiatives with measurable outcomes;
Experience working for a global health authority is considered advantageous.

Knowledge & Other Requirements:

Significant knowledge of the biopharma industry, as evidenced by proven track record in setting short- and long-range business strategies and plans;
Expert knowledge of the drug development process and GxP requirements (i.e., clinical studies, post-marketing/pharmacovigilance, and labs);
Thorough knowledge of standards, systems, policies and procedures that enable QMS operations and compliance within the biopharma GxP environment;
Demonstrates strong strategic and analytical skills, with strengths in assessing complex information and understanding the quality and compliance implications;
Proven abilities to anticipate problems of varying complexity and lead, and if necessary negotiate, the resolution of these in a collaborative manner across functions;
Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives;
Strong interpersonal skills and understanding of team dynamics, enabling negotiation and conflict resolution skills;
Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees;
Strong coaching capabilities to mentor/develop staff;
When needed, ability to travel.

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