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You will be updated with latest job alerts via emailAt Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Supply Chain ManufacturingJob Sub Function:
Manufacturing Pharmaceutical Process OperationsJob Category:
People LeaderAll Job Posting Locations:
Gurabo Puerto Rico United States of AmericaJob Description:
About Innovative Medicines
Our expertise in Innovative Medicine is advised and encouraged by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments finding cures and groundbreaking the path from lab to life while encouraging patients every step of the way.
Learn more at are searching for the best talent for a Senior Operations Manager to be in Gurabo PR!
The incumbent is responsible for providing leadership and oversight to the manufacturing operations at the Biotherapeutics Site. This role encompasses defining a strategic vision and guiding the team towards achieving operational excellence. Ensures compliance with Good Manufacturing Practices (GMP) FDA DOH CPMP Safety Environmental regulations and other regulatory agencies. Plays a relevant role in maintaining compliance across all processes to uphold the integrity of the operations.
The focus is to optimize the utilization of labor materials and equipment as well as maintain and improve cost quality compliance and production standards across the manufacturing areas. This involves analyzing operational data and implementing strategies to improve efficiency and productivity. Additionally champions a culture of continuous improvement within the Biotherapeutics platform at J&J Innovative Medicines Gurabo. This includes encouraging innovative thinking engaging employees in problem-solving and promoting standard processes to ensure sustained operational advancement.
Key Responsibilities:
Formulates and defines department goals and objectives and develops a roadmap to delivers them.
Promotes and model a culture of accountability and right first time in the End-to-End (E2E) Value Stream of products under Biotherapeutics.
Leads and maintains areas of responsibility in compliance with regulatory agency requirements and identifies and addresses compliance issues in a timely manner. Partner with Quality Assurance and Regulatory Compliance teams to maintain an audit ready facility quality and production systems and manage a team of subject matter experts.
Partners with Global Planning in an effort to deliver the business plan at the highest quality safety and at the lower cost possible.
Drives accountability for performance with metrics related to events deviations audits trainings corrective and preventive actions (CAPAs) and develops action plans and metrics to address any identified gaps.
Ensures the sustainability of flexible workforce strategies including career ladder structures internal and intra-site cross-training programs. Identifies the knowledge skills and abilities required for effective execution of operations.
Develops and adheres to the operating budget for the department.
Supports process development and continuous improvement efforts to optimize manufacturing operations.
Demonstrates leadership imperatives based on their level within the organization (People Leader).
Builds and maintains connections with external suppliers and networks to develop and implement strategic recommendations that improve global supply reliability.
Qualifications
Education:
Bachelors or higher degree is required. A masters and/or focus degree in a scientific field degree is highly preferred.
Green or Black Belt and/or Lean Certification is desirable
PE/PMP/FPx certification is a plus
Experience and Skills:
Required:
At least 8 years of overall experience in a pharmaceutical environment
A minimum of 5 years of management experience
Experience in the areas of Parenteral Manufacturing including Lyophilization Technology Optical Inspection and /or EU Annex 1 regulation
Proficiency in the use of Enterprise Systems MS Office applications including MS Teams (or ZOOM) Word Excel Power Point Outlook and Edge.
Preferred:
Experience in Quality Assurance Technical Operations Process Excellence or Engineering in the pharmaceutical or biotechnology industry.
Other:
Must be bilingual in Spanish and English and have excellent writing and communication skills.
Availability to travel both domestically and internationally approximately 10% of the time
Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.
Required Experience:
Manager
Full-Time