The Senior Director, BioResearch Quality & Compliance Head of Pharmacovigilance Quality Assurance (PV QA) is a key, strategic role that drives and shapes enhanced quality and compliance in the PV system globally. The Head of PV QA is accountable for the implementation and delivery of a proactive risk management program and the development and execution of a global PV audit strategy to ensure the functions, processes, and systems for Janssen Pharmaceutical Companies, partners, and any agreed cross-sector activities are in compliance with company standards, Good Practices and Health Authority regulations & guidelines.
The Head of PV QA is a member of the QA Leadership Team, responsible for driving innovation, talent development and acquisition, overseeing QA resource requirements, deliverables, and metrics. This role leads and develops multiple teams of quality assurance professionals, directly managing staff consisting of senior compliance professionals. This role manages company-wide complex issues and interfaces with management on a regular basis.
Decisions made at this level have significant implications for compliance across the Pharmaceutical sector and other sectors, as appropriate, as part of the BRQC Cross-Sector strategy.
This role reports directly to the Vice President, Head of BRQC Quality Assurance.
Audit Program Infrastructure:
- Lead PV QA Team to develop tactical and operational audit plans, utilizing a data- driven, risk-based process to deliver the PV QA audit strategy.
- Oversee the development and management of E2E PV QA audit processes, including audit scoping, preparation, execution, follow-up, and Corrective & Preventive Action (CAPA) to meet internal and external regulatory guidelines and standards.
- Collaboration with business partners to develop root cause analysis & CAPA Effectiveness check (EC) to ensure development approach is holistic and facilitate EC approval.
- Ensure effective performance of pre-inspection visits are performed to drive inspection readiness
- Lead the PV QA Team through the implementation of transformational change strategy by fostering an agile business climate that readily adapts to evolving business needs.
- Adopt data science and new technologies to innovate and transform PV QA activities.
Inspection Readiness and Management
- Drive inspection preparation strategy as well as support in managing of preclinical Sponsor / Monitor Inspections of Janssen
- Ensure effective performance of pre-inspection visits are performed to drive inspection readiness.
- Apply risk evaluation and knowledge management strategies into day-to-day activities.
- Partner within BRQC and with business partners to implement a fit for purpose PV integrated risk management program to support business-critical activities.
- Enable the identification and management of systemic PV risks and ensure adequate proactive mitigation plans are in place to drive resolution.
- Collaboration with PV-related business functions to promote a culture of proactive risk management.
- Contextualize quality risks and proposed proactive mitigations to senior management.
Licensing and Acquisition Support: Provide strategic direction and QA resourcing in support of integration plans following a license or acquisition deal.
Oversight & Monitoring: Evaluate & monitor efficiency & effectiveness of PV QA Activities.
Policies & Procedures: Support and champion audit process optimization (innovative audit approaches & continuous improvement ahead of industry standards) and foster alignment of audit processes across domains. Requires the ability to apply strategic vision to develop and implement new policies and procedures.
Corrective Actions & Escalations: Demonstrate leadership and sound business ethics in review of potential scientific misconduct or fraud instances and adequate escalation of critical compliance issues. Proactively identify quality events and escalate concerns in a timely manner; advise solutions to quality concerns in the PV domain.
Strategic Oversight: Progress and champion quality oversight strategy, balancing short- and long-term visions to ensure sustainable resourcing strategies.
Governance: Participate in governance board discussions, regarding compliance issues. Support the preparation and execution of various governance bodies (e.g., Management Review, Stage Gate Review, OCC and CCC) with QA content.
Team Leadership: Provide strategic leadership, coaching, and mentoring to direct reports and extended members of the QA and BRQC team. Attract, develop, and lead a high performing, global, and diverse team to support BRQC and Quality & Compliance.
Decision making and problem solving:
- Big Picture Innovation: Requires the ability to take a broad perspective to help anticipate internal and external opportunities and challenges. Uses creativity and imagination to develop new insights into situations and applies new solutions to problems.
- Project Management: Requires leadership and support of projects, meetings, etc., in support of the QA strategy. Oversees PV QA participation in key project initiatives, ensuring effective participation and global alignment.
- Change Management: Promotes a working environment that challenges the status quo; and leads and adapts to change, creating a positive culture. Must have the ability to resolve strategic BRQC QA challenges/issues with QA LT, BRQC SLT and Business Partners.
- Operates with minimal guidance from supervisor.
- Expected to lead and be proactive in the setting of priorities to achieve BRQC QA objectives.
- Establishes business unit strategies and sets priorities to achieve goals and objectives within the PV QA domain.
- Leads a team of QA professionals, directly managing staff of team leads, domain experts, and auditors.
- Champions coaching and mentoring for success across BRQC QA and the entire BRQC organization.
- Expected to collaborate with, and closely manage project teams, inclusive of QA, BRQC and business partners.
- Develops and implements talent strategies; shapes the environment for growth and development within the QA organization.
- Requires exemplary relationship building skills and the ability to influence without authority.
- Incumbent for this position will collaborate with individual employees and all levels of management within QA, across BRQC and with R&D and Commercial business partners.
- Must have demonstrated experience collaborating and communicating with senior levels of leadership.
- Works closely with other BRQC QA LT members and BRQC functions to influence or execute strategies.
- Creates and maintains a unified partnership with BRQC functions to provide one voice for quality risk assessments, remediation & business partner support.
- May interact with quality professionals outside of J&J as part of benchmarking or information exchange opportunities.
Minimum knowledge, education, experience, and skills required:
- Requires a minimum 15 years of businessexperience.
- Must have comprehensive knowledge of worldwide Pharmacovigilance, GCP, IT, and QMS compliance regulations andguidelines.
- Experience with driving innovative transformation, including building culture and leading change management across a largeorganization.
- Provides an optimisticviewpointandeagertodrivechangetothe statusquo.
- BS required. Masters in related field, advanced degreedesirable.
Working conditions and approximate travel requirements:
- Working conditions require resolution of complex problems within tight timelines.
- This position can be based at any EU site with BRQC presence (High Wycombe, Beerse, Leiden, Issy-les-Moulineaux) – other EU locations may be considered.
- Travel requirements: approx. 10-20% global travel may be required. In time of temporary workload peaks, travel may temporarily exceed this figure.
United Kingdom-England-High Wycombe-
Europe/Middle East/Africa-France-Haute-de-Seine-Issy Les Moulineaux, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Cilag Ltd. (7360)