Senior Account Specialist, External Quality Expert
6 days ago
We are seeking a highly skilled Senior Account Specialist to join our team at Johnson & Johnson Innovative Medicine. As a key member of our External Quality team, you will be responsible for providing quality oversight of external manufacturers in the Americas region.
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.
- Bachelor's Degree in Engineering, Science, or an equivalent technical discipline.
- A minimum of six (6) years working in an FDA regulated environment.
- Experience with quality support of clinical or commercial manufacturing operations.
- Experience in aseptic processing.
- Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production.
- Strong interpersonal and written / oral communication skills.
- Ability to quickly process complex information and make critical decisions with limited information.
- Proficient in applying process excellence tools and methodologies.
- A competitive salary range of $90,000 to $144,900.
- An annual performance bonus.
- A comprehensive benefits package, including medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- A consolidated retirement plan (pension) and savings plan (401(k)).
- A long-term incentive program.
- A generous time-off policy, including vacation, sick time, holiday pay, and work, personal and family time.
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.
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Horsham, Pennsylvania, United States J&J Family of Companies Full timeJob SummaryWe are seeking a highly skilled Senior Account Specialist to join our team at Johnson & Johnson Innovative Medicine. As a key member of our External Quality team, you will be responsible for providing quality oversight of external manufacturers in the Americas region.Key Responsibilities:Ensure effective and compliant execution of quality systems...
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