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Senior Manager, Business Development Quality Assurance
Location:
Westborough, MA
Description:
Working Location:MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY Workplace Flexibility:Field Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together. Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years. Our Purpose is to make people's lives healthier, safer, and more fulfilling. Our Core Values are reflected in all we do: Integrity : Empathy : Agility : Unity : Long:Term View We deliver on our purpose and our core values by staying True to Life. Job Description The Sr. Manager, Business Development Quality Assurance will support Quality Assurance M and A activities throughout the project lifecycle. This role will participate in due diligence of targets and identification of potential compliance risks which could impact the business. The Sr. Manager will identify resourcing and budgeting needs to effectively mitigate the identified risks. This role also participates in transition service planning, integration planning, and integration execution post:close to ensure a smooth transition and integration into Olympus Quality System occurs. This role will be responsible for development of Integration Quality Plans, training, and execution to those plans which requires close collaboration with the Quality Assurance subfunctions. Job Duties: Perform due diligence and communicate Quality Assurance risks associated with the target.: Define and evaluate compliance risks and develop mitigation plans to address the risks.: Identify resourcing and budgeting needs to appropriately mitigate risks; communicate these needs to the Quality Assurance BD Lead and BD core team members to be included within the deal model to ensure effective execution of risk mitigation activities.: Develop quality plans for integration into the Olympus Quality Management System following M and A.: Train the integration team to the execution of integration quality plans: Support the functional integration leaders during integration planning and execution.: Utilize the BD playbook to develop Quality integration plans and communicate suggestions for continuous improvement.: Work cross functionally with Olympus team members supporting Business Development activities to ensure system integration.: Build and maintain a network of resources in all regions, across all businesses and divisions.: Integrate the target site into the Olympus quality culture and ensure cohesive transition into full integration. Stay up to date on the latest global regulations.: Collaborate closely with the Quality, Regulatory, R and D, Business Development, Medical and Scientific Affairs, IT, and Operations functions.: Other BD project related tasks and deliverables as determined by the Quality Assurance BD Lead. Job Qualifications Required: : Minimum requirements are a BA/BS degree or equivalent in Engineering or Physical Science with an advanced technical degree and/or MBA preferred.: Minimum of 10 years of Quality Assurance experience in the Pharmaceutical or Medical Device industry (Medical Device preferred).: Strong prior experience in Quality Assurance initiatives including post market surveillance, complaints management, quality KPls, Design Controls, Risk management, CAPA, Quality Management Review, Audits, and Supplier Quality.: Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry such as: ISO, QSR, GMP, GLP.: Experience in Business Development M and A projects including due diligence, integration planning, and project management.: Travel: Position requires up to 20 travel both domestic and international.: Experienced in strategic planning and risk management.: The ability to lead
Posted:
May 1 on Tip Top Job
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More About this Listing: Senior Manager, Business Development Quality Assurance
Senior Manager, Business Development Quality Assurance is a Quality Assurance BD, QA Job located in Westborough MA. Find other listings like Senior Manager, Business Development Quality Assurance by searching Oodle for Quality Assurance BD, QA Jobs.
Senior Manager, Business Development Quality Assurance is a Quality Assurance BD, QA Job located in Westborough MA. Find other listings like Senior Manager, Business Development Quality Assurance by searching Oodle for Quality Assurance BD, QA Jobs.