Company Background Johnson & Johnson (J&J) is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the consumer, pharmaceutical, and professional markets.
J&J employs approximately 126,500 people worldwide, deployed in more than 250 operating companies in 60 countries.
Products are sold throughout the world and serve a broad segment of medical needs ranging from baby care, first aid, and hospital products to prescription pharmaceuticals, diagnostics, and products relating to family planning, dermatology, and feminine hygiene.
Johnson & Johnson and its subsidiaries have built the most comprehensive base of health care businesses in the world, generating more than 70 per cent of company revenues from No.
1 or No.
2 global leadership positions in their respective markets.
Johnson & Johnson’s consistent performance has enabled the company to deliver an exceptional track record of growth that few, if any, companies can claim: 28 consecutive years of adjusted earnings increases and 50 consecutive years of dividend increases.
The company’s worldwide sales for 2020 were $82.5 billion.
For the 18th year, Johnson & Johnson was named one of FORTUNE Magazine’s Most Admired Companies for 2020 and was named 1 in the Pharmaceutical category worldwide for the 7th consecutive year.
Gartner, Inc., the world’s largest research and advisory company ranked Johnson & Johnson 3 on its annual 2020 Supply Chain Top 25 list which spotlights exemplary global supply chains.
J&J operates in three global sectors: Consumer Products, Medical Devices and Pharmaceuticals.
Position Summary The Senior Director, BioResearch Quality & Compliance (BRQC) Head of Preclinical Quality Assurance (QA) is a key, strategic role that drives and shapes enhanced quality and compliance in the Preclinical domain.
The Head of Preclinical QA is accountable for the implementation and delivery of a proactive risk management program and the development and execution of a global Preclinical audit strategy to ensure the functions, processes, and systems for Janssen Pharmaceutical Companies, J&J Medical Devices, J&J Consumer Health, and partners are in compliance with Health Authority regulations and guidelines, Good Practices and internal company standards.
The Preclinical Domain spans GLP, GCLP, Animal Welfare, and Discovery/non-GLP related work.
The Head of Preclinical QA is a member of the BRQC QA Leadership Team, responsible for overseeing QA resource requirements, deliverables, and metrics.
This role leads and develops multiple teams of global quality assurance professionals, directly managing staff consisting of senior quality and 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 quality and compliance across J&J business units.
Principle Responsibilities Main responsibilities will include, but are not limited to: Proactive Risk Management Develop and implement a fit for purpose preclinical integrated risk management program in close collaboration with key stakeholders to support R&D operations business-critical activities.
Enable the identification and management of systemic preclinical risks and ensure adequate proactive mitigation plans are in place to drive resolution.
Collaboration with preclinical business functions to promote a culture of proactive risk management.
Contextualize quality risks and proposed proactive mitigations to senior management.
Audit Program: Lead Preclinical QA Team to develop tactical and operational audit plans, utilizing a data-driven, risk-based process to deliver the Preclinical QA audit strategy.
Oversee the development and management of E2E Preclinical QA audit program, including audit scoping, preparation, execution, follow-up, and Corrective and Preventive Action (CAPA) to meet internal and external regulatory requirements, guidelines and internal standards.
Collaboration with business partners to develop holistic and effective Root Cause Analysis, CAPA Actions, and Effectiveness checks (EC).
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.
Licensing and Acquisition Support: Provide strategic direction and QA resourcing in support of integration plans following a license or acquisition deal.
Transformation Leadership: Lead the Preclinical 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 Preclinical QA activities.
Oversight and Monitoring: Evaluate and monitor efficiency and effectiveness of Preclinical QA activities.
Policies and Procedures: Support and champion QA process optimization (e.g., innovative risk management and audit approaches driving continuous improvement ahead of industry standards).
Requires the ability to apply strategic vision to develop and implement new policies and procedures.
Corrective Actions and 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 Preclinical domain.
Strategic Oversight: Progress and champion quality oversight strategy, balancing short
– and long-term visions to ensure sustainable strategies.
Governance: Participate and contribute to governance board discussions, regarding Preclinical risk and quality/compliance issues.
Support the preparation and execution of various governance bodies (e.g., Management Review, Stage Gate Review, GLP Steering Committee) 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 J&J Q&C.
Ensure global team is prepared for future business landscape by proactively upskilling staff in new product modalities, data science, technological advancements, etc.
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 Preclinical 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.
Independence/Autonomy 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 Preclinical QA domain.
Reporting Relationships Reports directly to the Vice President, Head of BRQC Quality Assurance.
Responsibility For Others Leads a team of global QA professionals, directly managing staff of team leads, strategy leads, 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.
Working Relationships/Interfaces 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 Leaders to influence or execute strategies and provide one voice for quality risk assessments, remediation and business partner support.
May interact with quality professionals outside of J&J as part of benchmarking or information exchange opportunities.
Qualifications KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS: Requires a minimum 15 years of business experience.
Must have comprehensive knowledge of worldwide Pre-clinical Regulations and Guidelines (GLP, GCLP, Animal Welfare, Discovery/Non-GLP).
In addition, a working knowledge of GCP, and GVP is preferred.
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/Travel Requirements Working conditions require resolution of complex problems within tight timelines.
This position can be based in the US (east Coast or California) or Belgium, EU.
Travel requirements: approx.
10-20% global travel may be required.
In time of temporary workload peaks, travel may temporarily exceed this figure.
Primary Location United States-Pennsylvania-Spring House-Welsh & McKean Roads Other Locations Europe/Middle East/Africa-Belgium, North America-United States-Massachusetts-Boston, North America-United States-Pennsylvania, North America-United States-New Jersey, North America-United States-New York Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2105953494W