Johnson & Johnson Consumer Health (JJCH) is currently recruiting a Sr. Specialist R and D Quality.

Johnson & Johnson Consumer Inc. is recruiting for Senior Specialist, R&D Quality and Compliance located in Fort Washington, PA.

At Johnson & Johnson Consumer Health, we’re here to change the world. We are a diverse group of leaders who think digital-first and push boundaries as much as we push ourselves. And, for other like-minded leaders out there looking to make their mark, we’ve got three words for you: change happens here.

We combine meaningful human insights and digital-first thinking to help people take better care of themselves and their loved ones. We believe in the power of new perspectives and insights to drive innovation. Our culture is diverse and inclusive – a place where being individually dynamic but collectively brilliant results in smarter solutions for all of the many communities we serve.

We are industry leaders, earning the #1 or #2 position in most of the categories in which we compete. Our iconic and beloved brand, including TYLENOL®, ZARBEE’S NATURALS®, NEUTROGENA®, AVEENO®, LISTERINE®, OGX® and JOHNSON’S®, are rooted in science and endorsed by professionals, helping more than 1.2 billion people live healthier lives every day, from their first day.

On November 12, 2021, Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with employee representative bodies, as required, and other customary conditions and approvals. It is anticipated that, following conclusion of the transaction, you will be an employee of an entity within the newly created Consumer Health company and your employment will be governed by that company’s employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you at an appropriate time and subject to any necessary consultation processes.

The Senior Specialist, R&D Quality and Compliance coordinates the administration of integrated and comprehensive quality systems and controls that are appropriate, effective, efficient and continuously improving in order to ensure that R&D functions are operating in full compliance with sound scientific practice, Current Good Manufacturing Practices (CGMP), and within Johnson & Johnson policies and Standard Operating Procedures. The Senior Specialist provides documentation quality review/approval, documentation maintenance and archival, quality inspections of product. Assist in compiling documentation to release R&D studies, provides mentorship on applicable Regulations (FDA, ICH, EU, and others) pertaining to business partners, supports GMP audits, and functions as the quality lead on new product introductions/development.

Key Responsibilities:

• Provide GMP documentation review and approval of batch records (Manufacturing, Packaging, and Labeling) and related documents, including Lab, Pilot, and Trial scale batches. Responsible for the quality inspection of supplies for R&D studies.
• Participate on R&D project teams as the Quality representative. The Specialist will work with product development teams relative to GMP issues, project plans, due dates, and problem identification and resolution along with assisting in reviewing documentation to release R&D studies.
• Prepare R&D Quality System Management Review (QSMR): Ensure logistic of meeting, collection of data and information, and assist management representative during the meeting by creating the meeting minutes and other documents required.
• Ensures projects are completed in compliance to GMP regulatory requirements (including 21CFR Parts 50, 54, 56, 58, 210, 211, 312, 314, 812, 820, and Annex 13), including training of R&D personnel.
• Identifies and raises quality related issues and deviations to study team and management. Participates in the generation of corrective and preventative action plans.
• Ensures GMP documentation maintenance, storage, and archival process, including the daily activities supporting this process.
• Contributes in the development and implementation of GMP and Quality & Compliance processes and procedures.
• Supports compliance activities by participating in audit readiness; assists in Internal and External audits.

• Minimum of a Bachelor’s Degree in Biology, Biochemistry, Microbiology, Chemistry or related scientific field is required.

• At least 9-12 years of proven experience in a pharmaceutical, consumer products or FDA Regulated environment is required
• Expert knowledge of applicable regulatory requirements (cGMPs and cGLPs) governing various product classification types (cosmetic, OTC/OTC Monograph and Medical Devices).
• Possesses extensive experience in relevant subject area such as CSV, GxPs, manufacturing, validation, analytical, quality systems, etc.
• Ability to work and make decisions independently and on multiple projects
• Ability to engage and align with other diverse and dispersed organizations and functions.
• Ability to independently plan organize, coordinate, manage and complete assigned tasks
• Excellent organization and time leadership skills, attention to detail, and ability to multi-task in environment with shifting priorities
• Excellent knowledge of English and proficiencies in Microsoft Office applications.

Preferred:

• Experience of the overall product development process.
• Knowledge of procedures governing R&D GMP, Analytical/Micro and GLP activities
• Proficiency in formulation or manufacturing of consumer/pharmaceutical products.

Other:

• Written and oral proficiency in the English language is required
• This position requires up to 10% travel based upon business needs.
• This position is on a hybrid work schedule; 3x/week onsite, 2x/week remote.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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.]