Johnson & Johnson Services, Inc. is recruiting for an Enterprise Business Engagement Liaison to be located at any J&J location with the United States!
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.
With $82.6 billion in 2020 sales, Johnson & Johnson 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 medical devices markets. There are more than 260 Johnson & Johnson operating companies employing over 135,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer
The Business Engagement Liaison uses insights obtained along with relevant regulatory requirements to develop audit strategies based on a ‘fit for purpose’ mindset. The Liaison also drives continuous improvement of the ERC audit program, including setting the ERC auditor strategies.
The position will support standardization all ERC audit support activities, driving improved and economized audit preparation, including risk-based scheduling, resourcing, pre-audit planning based on site type, products, technology and potential linkages to other sites, regions and site types. Leading to the objective of providing a holistic view of potential compliance risks across the J&J supply chain.
- Establish effective business relationships with key stakeholders within the J&J supply chain that will enable insights that are used to define ERC audit strategies.
- Provides recommendations for ERC audit program improvements to effectively assess GxP compliance.
- Sets strategies and executes analysis / report of ERC audit data. Collects and reviews audit metrics / data JJRC Compliance reviews.
- Assists in formulating & implementing ERC audit procedure improvements to be followed by the ERC auditors.
- Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings. Assesses proposed regulations and communicates new requirements to the organization.
- Establishes and maintains centralized audit scheduling and resource planning across all ERC audits.
- Leads or supports JJRC base business projects and initiatives, as required (including ERC auditing).
- A minimum of a Bachelors degree (BS/BA) or equivalent 4-year degree is required, preferably with a focused degree in science, engineering, organizational manager or other related field.
- A minimum of 8 years of experience in a QA & Regulatory Compliance role within a Pharmaceutical, Medical Device and/or OTC Drug Industry environment
- Strong Quality and Compliance background with a deep understanding of Global cGMP requirements and the systems used to deploy them.
- Strong understanding and experience with process remediation.
- Strong understanding of product / process development principles, including regulatory filing / approval processes across all segments of the business, product types and regions.
- Experience in performing GxP audits, including the development of risk-based audit strategies, audit planning, conducting audits and reporting audit outcomes in a concise manner.
- Strong problem-solving skills, Negotiating skills, influencing skills, and developing relationships.
- Excellent written and oral communication & Financial acumen
- Strong decision making and analysis skills and Strong interpersonal skills, including ability to communicate with individuals and groups at all levels
- Global experience
- Experience working in Medical Device
- ISO Certified Lead Auditor
- ASQ Certified Auditor
- Working knowledge of data analytics tools such as Spotfire
- May require up to 20% of domestic and international travel
- The anticipated salary range is $115,000 to $175,000
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .