Manufacturing Quality Assurance Manager

Company: Merck
Location: De Soto
Posted on: May 20, 2023

Job Description:

Job DescriptionOur Quality Assurance Group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.We are seeking a growth and improvement minded Manufacturing Quality Assurance Manager that can help drive our Strategic Operating Priorities:Invent - Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical NeedsExecute - Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base BusinessAdapt - Develop Our People, Culture and Business Model to Evolve with a Dynamic LandscapeDiverse Talent - We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the worldValues and Standards - Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us Summary, Focus and Purpose The selected candidate will provide daily compliance oversight and guidance to Quality Assurance and Manufacturing personnel. Responsibilities will include managing systems for manufacturing deviations, change controls, validations, batch disposition, and qualification activities against regulatory guidelines and quality standards.
Key Functions Work Independently and as a Team member with Integrity - Precision - Accomplishment - Motivational Ambition - Respect - InclusionLeadership, feedback, and coaching to Quality Assurance colleagues through routine performance evaluations and responsibility oversightCompliance oversight and guidance for upstream and downstream Manufacturing, Engineering/Maintenance and other departmentsActively contribute to process teams by providing guidance and oversight in relation to the CFR and Quality StandardsParticipate in manufacturing walks and internal auditsOversee disposition of raw materials and liquid vaccinesQuality systems including Deviations, CAPAs, and Change ControlsDrives continuous improvement of all quality systems and processesAssist with or communicate directly through verbal and/or in writing with regulatory authoritiesParticipates in and provide direct guidance during external audits and inspectionsOversight of site Quality Management systemsManage QA budgetCommunicate product quality problems and provides metrics for the Tier meetings, Quality Review Council, and Extended Leadership Team meetings Education Require - High school diploma or equivalentPreferred - Bachelor or advanced degree Experience - Knowledge - Skills
Required Five plus years of demonstrated leadership, feedback, and coaching experienceFive plus years in a Quality or Manufacturing rolePrincipled verbal and written communicationsDemonstrated ability to lead and work within a teamConsistent decision making and ability to act according to a strategic planRoot cause analysis and troubleshooting skillsProficiency with applicable computer systemsAttention to detail and ability to work within quality systemsTechnical writing skillsPreferred Working in a regulated aseptic manufacturing environmentKnowledge of or experience in Lean, Six-Sigma or Operational ExcellenceOur Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.Who we are ...We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.What we look for ...Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact 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 HERE Current Contingent Workers apply HERE Secondary Language(s) Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.We are seeking a growth and improvement minded Quality Assurance Manager that can help drive our Strategic Operating Priorities:Invent - Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical NeedsExecute - Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base BusinessAdapt - Develop Our People, Culture and Business Model to Evolve with a Dynamic LandscapeDiverse Talent - We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the worldValues and Standards - Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us Summary, Focus and Purpose The selected candidate will provide daily compliance oversight and guidance to Quality Assurance and Manufacturing personnel. Responsibilities will include managing systems for manufacturing deviations, change controls, validations, batch disposition, and qualification activities against regulatory guidelines and quality standards.
Key Functions Leadership, feedback, and coaching to Quality Assurance colleagues through routine performance evaluations and responsibility oversightCompliance oversight and guidance for upstream and downstream Manufacturing, Engineering/Maintenance and other departmentsActively contribute to process teams by providing guidance and oversight in relation to the CFR and Quality StandardsParticipate in manufacturing walks and internal auditsOversee disposition of raw materials and liquid vaccinesQuality systems including Deviations, CAPAs, and Change ControlsDrives continuous improvement of all quality systems and processesAssist with or communicate directly through verbal and/or in writing with regulatory authoritiesParticipates in and provide direct guidance during external audits and inspectionsOversight of site Quality Management systemsManage QA budgetCommunicate product quality problems and provides metrics for the Tier meetings, Quality Review Council, and Extended Leadership Team meetings Education High school diploma or equivalent Experience - Knowledge - Skills Required Five (5)+ years of demonstrated leadership, feedback, and coaching experienceFive (5)+ years in a Quality or Manufacturing rolePrincipled verbal and written communicationsDemonstrated ability to lead and work within a teamConsistent decision making and ability to act according to a strategic planRoot cause analysis and troubleshooting skillsProficiency with applicable computer systemsAttention to detail and ability to work within quality systemsTechnical writing skillsPreferred Bachelor or advanced degreeWorking in a regulated aseptic manufacturing environmentKnowledge of or experience in Lean, Six-Sigma or Operational ExcellenceUS 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.
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Pay Transparency Nondiscriminatio n 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. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Learn more about your rights, including under California, Colorado and other US State Acts Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: RegularRelocation:DomesticVISA Sponsorship:No Travel Requirements: 10%Flexible Work Arrangements:Not SpecifiedShift:1st - DayValid Driving License:NoHazardous Material(s):N/A

Keywords: Merck, Olathe , Manufacturing Quality Assurance Manager, Executive , De Soto, Kansas