Johnson & Johnson Careers
SENIOR DIRECTOR QA CLINICAL DOMAIN HEAD
Requisition ID: 00001E01
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.
The Senior Director, BioResearch Quality & Compliance (BRQC) Quality Assurance (QA) Clinical Domain Head is a key, strategic role that drives and shapes enhanced compliance in the Clinical domain. The Clinical Domain Head is accountable for the implementation and delivery of the global clinical audit strategy to ensure the countries, functions, process and systems for Janssen Pharmaceutical Companies, partners and any agreed cross-segment activities are in compliance with company standards, Good Practices and Health Authority regulations & guidelines.
The QA Clinical Domain Head is a member of the BRQA Leadership Team, responsible for 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.
Main responsibilities will include, but are not limited to:
- Audit Program Infrastructure:
- Lead Clinical Domain Team to develop tactical and operational audit plans, utilizing a data-driven, risk- based process to deliver the domain audit strategy.
- Oversee the development and management of E2E domain 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.
- Transformation Leadership: Lead the Clinical Domain Team through the implementation of transformational change strategy by fostering an agile business climate that readily adapts to evolving business needs.
- Risk Management: Apply risk evaluation and knowledge management strategies in to the day to day activities.
- Oversight & Monitoring: Evaluate & monitor efficiency & effectiveness of BRQC Janssen QA Activities in the Clinical Domain.
- 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 Clinical 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 Janssen, BRQC, and Janssen Quality.
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 Clinical 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 Clinical QA domain.
- Reports directly to the Vice President, Head of BRQC Quality Assurance.
RESPONSIBILITY FOR OTHERS:
- 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 Janssen Quality Planning & Strategy (QP&S) 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.
KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:
- Requires a minimum 15 years of business experience.
- Must have comprehensive knowledge of worldwide GCP, GLP, PV, and IT compliance regulations and guidelines.
- Experience with driving Culture and Change Management across a large organization.
- Provides an optimistic viewpoint and eager to drive change to the status quo.
- BS required. Masters in related field, advanced degree desirable.
- Working conditions require resolution of complex problems within tight timelines.
- This position can be based at any EU/US site with BRQC presence: Raritan, NJ; Antwerp, Belgium; England, UK; South Holland, Netherlands or Paris, France.
- Travel requirements: approx. 10-20% global travel may be required. In time of temporary workload peaks, travel may temporarily exceed this figure.
United States-New Jersey-Raritan-
United Kingdom-England-High Wycombe, Belgium-Antwerp-Beerse, France-Île-de-France-Paris, Netherlands-South Holland-Leiden
Janssen Research & Development, LLC. (6084)