Johnson & Johnson is recruiting for a Senior Manager Supplier Quality located in Titusville, NJ, Raritan, NJ Horsham, PA, or Guaynabo, PR! At Johnson & Johnson we are working to build a world without disease. Transforming lives by finding innovative ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Johnson & Johnson. We collaborate with the world for the health of everyone in it. Learn more at www.jnj.com. This person will serve as the Quality Owner for Drug Delivery System based Suppliers in the Americas Region with quality relationship oversight. • The position acts as a subject matter expert for drug delivery systems, suppliers and related materials providing expertise globally, as needed, for Combination Products related Supplier Quality activities and issues. This position is the Quality process leader primarily for Higher Complex Suppliers, including accountability versus the related Stakeholders. Key Responsibilities:
- EQ-SQ member having the Quality oversight responsibility of the assigned Combination Products / Complex suppliers as part of IM Portfolio.
- Quality and Compliance lead ensuring quality standards are achieved and maintained at suppliers through management, and oversight on Quality Operations functions for external business partners.
- This position will primarily manage higher Complex Combination Products Suppliers, for quality and compliance status (e.g. impacted change control management / deviation / escalation / complaint handling / Specification alignment / Quality Agreement updating etc.).
- This position may Lead High Impact Projects typically from EQ (that could be linked to the annual company and division goals) or from Local IM SC site
- Lead and participate in strategic and optimization initiatives to improve EQ-SQ management processes
- Act as Global Quality Relationship Manager for the assigned related Suppliers providing a single aligned voice for supplier quality performance within J&J enterprise network
- Directly managing, coordinates and coaching the SQ Combination Products team and Indirect reports
Education: - A minimum of a Bachelor's degree, preferred Master's degree
Experience and Skills: Required: - A minimum of 8 years of experience in quality management, production, quality control, or R&D in a pharmaceutical and/or biotechnology environment
- Minimum of 5 experience leading external suppliers (External Manufacturing and/or Direct and Indirect Materials) specifically for Drug Delivery Systems - operations, quality, regulatory, compliance, external Manufacturing support etc.
- Familiar with GMP - and International Conference on Harmonization (ICH) - regulation
- Expert in DDS and Combination Product Regulations
- Expert demonstrating extensive knowledge and outstanding skill set to provide mentorship to others and develop balanced improvements in EQ-SQ
- Frequently collaborates with internal operating companies and R&D partners on a wide variety of product, process, project and compliance related issues.
- Interfaces with internal IM functional groups to broker the vital technical support for external partners.
- Exposure to regulatory authorities' inspections
- Ensure the training is completed in timely fashion
Preferred: - Interactions are required with Tech Ops, PDMS, Procurement, EHS, Planning, the different IM manufacturing sites, but also with the other quality groups within IMSC and on enterprise level, such as Compliance, Quality unit API manufacturing, Quality systems and the different Qualified persons.
- Selection, Qualification and Monitoring of Suppliers and EM, activities linked to Supplier Quality Management and training of new people
- Partners with Enterprise and IM leaders to establish process improvements and pro-active quality achievements.
Other: - This role may require up to 10% of domestic travel.
- The anticipated base pay range for this position is $118000 to $203550.
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))
- 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 of Work, Personal and Family Time - up to 40 hours per calendar year
- Additional information can be found through the link below.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. 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 .