Senior Account Specialist, External Quality - 2406202280W

Description

Johnson & Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is currently seeking a Senior Account Specialist to join our team located in Horsham, PA or Titusville, NJ! Remote work options may be considered on a case-by-case basis and if approved by the Company.

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 https://www.jnj.com/ .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

In this role you will be responsible for providing quality oversight of external manufacturers in the Americas region, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards!

Key Responsibilities:

• Ensure effective and compliant execution of quality systems at external manufacturing sites.

• Participate in the selection, qualification, and ongoing monitoring of external partners.

• Provide support in the identification and resolution of quality issues and complaints, including participation in investigation processes and development of robust CAPA plans.

• Review and approve quality system documentation, including product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies.

• Monitor quality performance, identifying trends, and support the development of appropriate mitigation plans.

• Establish relationships with internal and external partners, influence external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture.

• Provide support for health authority inspections and follow-up on associated commitments.

• Provide quality oversight for tech transfer and new product introduction activities, support associated health authority filings.

Qualifications

Education

• Bachelor’s Degree in Engineering, Science, or an equivalent technical discipline is required.

Experience and Skills:

Required:

• A minimum of six (6) years working in an FDA regulated environment is required.

• Experience with quality support of clinical or commercial manufacturing operations is required.

• Experience in aseptic processing is required.

• Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production is required.

• Strong interpersonal and written / oral communication skills is required.

• Ability to quickly process complex information and make critical decisions with limited information is required.

• Proficient in applying process excellence tools and methodologies is required.

Preferred:

• Experience working with external manufacturers is preferred

Other:

• This position will be located in Horsham, PA or Titusville, NJ and may require up to 10% domestic or international travel.

The anticipated base pay range for this position is $90,000 to $144,900.

– The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Company’s long-term incentive program.

• Employees are eligible for the following time off benefits:

– Vacation – up to 120 hours per calendar year

– Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

– Holiday pay, including Floating Holidays – up to 13 days per calendar year

– Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on August 2, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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 (https://jnjc.taleo.net/enterprise/www.careers.jnj.com) .

Primary Location NA-US-Pennsylvania-Horsham

Other Locations NA-US-New Jersey-Titusville

Organization JANSSEN SUPPLY GROUP, LLC (6046)

Travel Yes, 10 % of the Time

Job Function Quality Assurance

Req ID: 2406202280W