Bausch Health • Brooklyn, NY 11225
Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.
Our approximately 7,000 employees are united around our mission of improving people's lives with our health care products.
The Senior Quality Specialist provides support for the business' product development portfolio and ensures adherence to CGMP compliance in a regulated environment. You will support the Manager of R&D Quality and will be responsible for the effective management of the quality oversight and delivery of quality services supporting product development. The Senior Quality Specialist is instrumental in supporting Right-first-Time (RFT) culture in New Product Introductions (NPI) and will colaborate with multi-disciplinary internal and external teams in driving adherence to Quality-by-Design principles as well as compliance with relevant regulatory requirements and corporate standards. Partner with cross-functional project team in the development, review and approval of relevant CMC documentation that supports science driven process knowledge and understanding, risk management principles while remaining agile and customer centric approach.
This is a hybrid role and requires three days in office onsite in Bridgewater, New Jersey.
Review and approve Quality-by-Design principles documents such as TPP/QTPP, RA Strategy Document, Critical Material & Quality Attributes, Critical Process Parameters, Control Strategy, etc.
Facilitate GMP launch readiness activities, such as:
Stage gate reviews for validation, launch, etc.
PAI or other inspection readiness plans
Review and approve GMP documents (e.g., production batch records, lab batches, API and raw materials, product specifications, analytical and micro work order reports, standard test methods, standard operating procedures, protocols for method validation, method validation reports, stability protocols and stability reports, equipment IQ, OQ. PQ qualifications and equipment calibration).
Review and approve deviation and OOS investigations.
Review and approved method transfers.
Facilitate GMP product readiness and launch activities, including stability strategy, technology transfer and validation.
Ensure timeliness and integrity of work.
Understand technical procedures and be able to verify accuracy of calculations.
Support new product development and CMO/CDMO activities for both consumer and Rx products.
Review and release labelling jobs performed on site.
Review and release finished product clinical trial materials manufactured by CMOs/CDMOs.
Support/lead knowledge transfer from development to commercial quality team
Support/lead the development of risk management plans, risk assessments, to support new product development
Define and develop the quality strategy for the lifecycle management of the project (Quality plan/quality strategy).
Bachelor's Degree in scientific discipline such as chemistry, pharmacy, engineering
Experience in a regulated manufacturing environment, analytical laboratory, or in methods development
Experience in application of QbD, and/or Lean Six Sigma
This position may be available in the following location(s): [[location_obj]]
We thank you in advance for your interest in growing and developing with Bausch Health. Kindly note that in order for all stakeholders to be successful, we do require a minimum of one year in your current role before applying to another one. Please ensure you have discussed with your current manager the intent of applying to a new role.
Any exception will have to be authorized by your HR Business Partner.
Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to ~~~ or call ~~~ and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Bausch Health's Job Offer Fraud Statement (~~~) .
Bausch Health is an EEO/AA employer M/F/D/V.
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