EXTE RN/Registered Nurse AL SITE QUALITY LEAD ESQL

An amazing opportunity has arisen for an External site Quality Lead.
The incumbent is accountable for all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings, and company policies.
The incumbent also ensures that effective and robust Quality systems are followed to comply with required regulations, policies and guidelines governing the External manufacture of materials for the Company (e.g., small molecules active pharmaceutical ingredients, intermediates, raw materials) through direct oversight, support and technical advice, counselling to site leadership, and on-site supervision.
The Associate Director may serve as a subject matter expert for EQA and Division in specific Quality systems, technology platforms, regulatory expectations and/or EE management, and can represent the Company in forums on their area of expertise (both internal & external).This position can be located within the United States of America, preferably close to one of our company's manufacturing sites.
Amount of Travel Required:
Ability to travel up to 25%, occasionally on short notice.What you will do:
Bring energy, knowledge, innovation, and leadership to carry out the following:
Exhibits our company Leadership Behaviors and provides a leadership example for the team.Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.) both domestic and foreign.Maintains and provides expertise on EQA systems, tools, data, and processes on an ongoing basis.Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.May sponsor the interpretation and aggregation of financial/business data for EQA and highlight concerns as appropriate to EQA Management.
Identifies and facilitates resolution of major deviations from financial or strategic plans.Accountable for oversight of an EE involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight.
These components may include review of batch documentation and deviation investigations.Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews.
This also includes building effective quality systems at the EE and continuous improvement activities.Operates in a safe and efficient manner and in compliance with the Safety and Health Policy.Minimum Education and Experience Required:
Bachelor s degree of Science (BS) in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred with ten (10) years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.Required Skills and Experience:
Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.Communicates in English, both verbally and in writing.
Moderate level of contractual and financial awareness.
Previous experience participating in regulatory inspections.
Be conversant with all domestic and foreign regulations and compendia governing plant operations.As a company, we are committed to Inventing for Life in all that we do.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world s most challenging healthcare needs.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.So, if you are ready to:
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
Please click here if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.
All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.
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