Global Head, PDQ Quality Assurance Process & Affiliates

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The Position

Job Purpose:

The PDQ Quality Assurance Process and Affiliate (QAPrA) Global Head is accountable to the Roche/Genentech Organization in providing strategic leadership and direction to the global Quality Assurance Process & Affiliate teams who are responsible for the strategic design and delivery of Quality Assurance Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Medical Device and Computer Systems (CS) activities conducted by Product Development, gRED, pRED, Pharma International and development/licensing partners. The role ensures Quality Assurance Process & Affiliate have defined Critical to Quality (CtQ) objective outcomes based on business surveillance and the use of data analytics at a Process/Country level. As a member of the PDQ Senior Leadership team (QMLT), this role co-leads the development and delivery of the PDQ Quality Oversight Strategy, including leading Health Authority inspections, and the delivery of Quality Assurance positions for global Process and Affiliates, including Genentech that facilitate governance and maintenance of Roche Pharma’s license to operate.

Primary Responsibilities and Accountabilities:

Provides transformational leadership and direction to the Quality Assurance Process and Affiliate delivery workforce towards the PDQ vision of accelerating HA review & approval cycles, and reducing the risk of negative outcomes (delay, non-approval or removal of approval/license to operate) from regulatory inspections of Roche products, and Roche legal entities.

Motivates and manages team members across multiple geographies so that employees are developed, contribution is maximized and performance is actively managed. Ensure all employees have clear roles and responsibilities and that communication and employee relations are managed.

Develop and refine global strategy focused on the design and implementation of Process and Affiliate Quality Assurance in support of Roche product portfolio success.

Define annual goals and initiatives for staff supporting consistent execution of strategy and people development, lead the management of resources to deliver business objectives.

• Ensures the preparation, conduct and reporting of activities as part of the delivery of a business enabling Quality strategy for global processes and affiliates

• Ensure consistency in implementation of PDQ processes and procedures

• Ensure activities are conducted and reported in compliance with department procedures

• Ensure resources and budget adherence for the execution of activities

• Provide oversight of any consultants/contract organizations conducting activities on behalf of PDQ-QAPrA

Participates and partners with the PDQ Senior Leadership Team to provide input into the development of PDQ strategy, goals and objectives

• Develop annual goals and objectives

• Contribute to the review and revision of the PDQ vision, mission and strategic objectives

• Partner with PDQ senior leadership team to develop and deliver PDQ Strategy

• Supports and/or leads PDQ functional initiatives

• Contributes to the strategic optimisation of PDQ business process and systems

Provides leadership and direction to PDQ and our customers/stakeholders on GxP related activities/issues

• Co-Chair of the Roche Medical Device Council

• As Co-Chair, lead escalated Medical Device Compliance topics at the Roche Quality Oversight Council and Chief Medical Officer Oversight meetings

• Represent the Quality Assurance QAPrA team/PDQ in discussions within the Roche Group (such as the provision of Process and Affiliate positions for Group Sustainability and Pharma Leadership team Management Reviews of Quality) and key representations externally with industry and government regulatory agencies.

• Engages and influences

  • the Pharma organization (REDs, PD, Pharma International and Genentech) towards the common purpose of strong outcome focused Quality positions enabling business success.

  • at the various levels of compliance oversight within the organization (Process Oversight - GPO, GxP System Oversight - Governance Councils, Pharma System - Management Review of Quality)

Leadership of global Health Authority inspections of Roche process and legal entity GxP and Medical Device regulated activities

• Leadership of Local and Global Health Authority inspections of Roche process and systems across the GxPs

• Support pre-approval inspection preparation, pre-filing engagement and management of major Health Authority inspections

• Ensures responses provided to inspection reports and commitments are tracked to completion

Maintain knowledge of Global HR Corporate policies and procedures

• Maintain highest level of awareness and expertise in international GCP, PV, CS and GLP regulations, internal policies and SOPs

Professional and Technical Requirements:

Education/Qualifications:

• Masters, Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience

• Advanced degree in referenced fields preferred

• Significant years of experience in the pharmaceutical industry and/or Quality Assurance

• Considerable experience in GCP/PV/CS/GLP audit program management

• Proven success within supervisory/management experience

• Demonstrated knowledge of GCP, GLP, CS and pharmacovigilance / drug safety and regulatory requirements

• Budget management; as well as analytical, organizational and planning skills

Desired Expertise:

• Managing global teams of Line Managers, managers of managers and auditors

• Experience supporting regulatory authority inspections

• Audit program design and methodology including CAPA Management

• Proven capability in setting strategic direction and managing autonomous teams with proficiency in translating strategies into activities that generate Quality evidence which can enable business objectives

• Familiarity with using analytics and data visualization tools

Experience, Skills, Knowledge:

• Demonstrated knowledge of GCP, GLP, PV/Drug Safety & Medical Device regulatory requirements as they pertain to systems/procedures adopted within, and or related to, Roche Pharma in the conduct of business

• Effectively formulates strategies, tactics and action plan to achieve results

• Demonstrated ability to effectively communicate, influence and lead both with and without authority

• Highly effective teamwork and collaboration skills

• Global team leadership and people management

• Proven project management skills with ability to lead multiple teams

• Demonstrated analytical, problem solving and decision-making skills

• Proven success in leadership, strategic and system thinking

• Expert knowledge of drug development processes, inspection management and GxP/CS regulations

• Proven ability to influence and negotiate effective solutions within PDQ, PD, and/or industry through leading change and driving for results

• Has an established network to collect industry intelligence and thus potentially influence strategic objectives

• Proven record of working in an international, multicultural matrix organization

• Fluency in written and spoken English

• Demonstrated knowledge of product development related global regulatory requirements

Other:

• Availability to travel up to 40%

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more .

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.