Manager, Clinical QA Program Lead (2 openings)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Clinical Quality

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Manager, Clinical QA Program Lead-Two Openings! This position can be located in Raritan or Titusville, NJ, Horsham or Spring House, PA, Allschwil, Switzerland, Beerse, Belgium, High Wycombe, UK, Shanghai ,China and Madrid, Spain.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
North America- Requisition #R-094130
EMEA– Requisition# R-094833

Main responsibilities will include, but are not limited to:
Audit strategy:

• Drives and delivers audit strategies and capabilities for applicable therapeutic program level(s), Clinical System, Clinical Supplier, or Local Operating Company audits, ensuring connectivity and holistic alignment of strategies.

• Fosters the partnership between audit strategy and execution teams and enhance the value of Clinical audit programs through enhancing the audit report peer review process and the analysis and communications of meaningful audit outcomes.

• Monitors audit outcome trends and identification of pro-active collaboration opportunities with stakeholders to resolve and address compliance related matters and identify opportunities to enhance audit strategy and overall quality and compliance of clinical programs across therapeutic areas.

• Maintains and shares expert-level GCP knowledge with the ability to provide critical information, advice and guidance on complex quality and compliance issues.

• Leverages data analytics tools to analyze relevant data sources. Evaluate and analyze the data to identify any relevant trends and insights as an input for the development of the appropriate audit program.

Audit execution:

• Conducts GCP audits & supports GxP Audits as applicable (expected up to 50% time) with a focus on audits relevant to the responsible therapeutic areas.

• Develops tactical and operational audit plans to implement and deliver domain-specific audit strategies. Ensures the relevant standard procedures, audit scopes and audit plans are fully understood and applied in audit activities.

• Independently leads and manages the domain-specific compliance audit programs as laid down in a comprehensive audit schedule, through planning, conducting and reporting of QA audits of activities, data, internal and external facilities and processes in GxP/non-regulated areas to assure adherence to company internal standards and policies/requirements, and compliance with applicable (Health Authority) regulatory requirements. This includes for cause, complex and business critical audits.

• Guides auditors in the scope definition, planning, conduct and reporting of audits, providing regulatory and process expertise within the applicable therapeutic area program(s).

• Prepares and reviews audit summary reports (or any materials) to share/escalate significant information with senior leaders.

• Proactively seeks solutions and contributes to the strategic direction for the execution of the audit plans, schedule and inspection-related activities. Influences the effective implementation of aud