The Manager, Sample Operations is responsible for the Sample Accountability/Management under the PDMA guidelines to ensure FDA compliance implemented for any sampling through personal and non-personal promotion. The Manager is also responsible for leading and maintaining sample shipment programs (Representative and Direct to Practitioner) operations and administration with internal departments and the vendor. Vendor management to ensure all guidelines and processes are implemented to adhere to PDMA requirements and Company policies.
The Sr. Manager/Assoc. Director within Nonclinical Safety will support the research and development of new ophthalmic medical device products as well as maintenance of business activities by ensuring that adequate documentation exists for all new and existing products to meet existing and emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993 series.
Support the Clinical Quality Assurance function within Development and Research Operations with primary responsibility for managing non-conformance and change control systems and providing GCP guidance for day to day operations. Secondary responsibilities include supporting GCP training, conducting system, study, site and vendor audits.
Product Manager - Digital Marketing position is responsible for leading and implementing Bausch & Lomb US Surgical digital marketing efforts to help achieve market growth and revenue objectives This role will execute marketing strategy to support lead generation, acquisition, retention and win-back across online channels including; website, marketing automation, mobile app, social media, email. This role in partnership with US Surgical Brand marketing and Bausch Health corporate IT will develop marketing business requirements to enhance and develop digital marketing systems and support development and implementation of all digital marketing campaigns and initiatives across the marketing automation continuum. We seek high performers who are creative and can leverage their digital experience in developing solutions and managing initiatives that will surprise and delight our customers. Candidate should have excellent written and oral communication skills, strong interpersonal skills and a passion for digital technologies. This role is currently listed as a Marketing Manager but is commensurate with candidates’ level of previous experience.
The primary role of this position is tosupport the development, validation, implementation and trouble-shooting of analytical methods and the collection of data to set specifications applicable to new or existing generic pharmaceutical drug products.
The Manager/Senior Manager, Analytical Development will support the analytical development function generic portfolio of product development candidate(s). The individual will have responsibility for the oversight of internal / external analytical development activities pertaining to drug substance process and drug product formulation development, and product characterization.
Provide technical oversight and maintain quality systems that are effective and comply with federal, state, local, and other applicable regulations and standards, as well as in accordance with internal Bausch & Lomb policies and procedures for the St. Louis site Disposable Value Stream.
Provide technical oversight for cleanroom and terminal sterilization (Gamma & ETO) processes.
Report on the performance of the quality system to the St. Louis site management.
Support product changes and new product development.
Monitor the effectiveness of quality improvements and validation activities as part of the CAPA process.
Manage processing of materials through finish product release.
Specific focus on Environmental Monitoring, Sterilization, Clean Room Procedures, Root Cause Analysis and Validation.
To carry out the day to day operation and supervision of production personnel involved in manufacturing of product for the facility. Maintains general control to ensure compliance with all regulatory requirements. Responsible for ensuring compliance is maintained in the area concerning environmental, health and safety practices. Directs and oversees Leads, Trainers and employees to accomplish established objectives.
Responsible for the continuous development and maintenance of Quality Systems at the B& L Tampa Pharmaceuticals Organization. Will also be responsible for various Quality System process improvements and Quality Assurance/System projects and Identifying and addressing Compliance Gaps. Work with cross-functional teams to develop/improve Quality Systems
Mentor, coordinate and manage the Aseptic Training team to ensure that Training requirements are met. Ensure timely completion of garment excursions.