Director Quality Assurance Infectious Diseases/Vaccines (Remote)

Merck Director Quality Assurance Infectious Diseases/Vaccines (Remote) Des Moines , Iowa Apply Now Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. The Quality Assurance Lead (QAL) will work independently, with limited guidance, to ensure implementation and management of the Quality Assurance strategy in a given Therapeutic Area (TA) across multiple programs, indications and/or regions. The QAL will ensure quality principles are considered throughout the drug development process, risk mitigation strategies for programs underway are implemented and quality metrics, including audits, are utilized to inform the business of the state of quality of the programs within their... respective therapeutic area. The QAL will utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of study participants. This role will be responsible to perform risk assessments to identify audit targets, conduct audits, develop and maintain audit tools, as well as, review audit reports. They will work to assure quality standards are consistently applied and will escalate resource and data quality matters to Senior Management as appropriate. Primary Responsibilities: Primary activities include, but are not limited to: Represents Quality Assurance (QA) as the single point of contact for programs in a certain TA or across TAs in a certain region and provides QA strategic guidance. Responsible for practical knowledge of current and emerging global guidelines and regulations, relevant regulatory approaches and actions and status of competitor/similar products/projects to effectively develop and advance QA strategies. Maintains robust audit and quality oversight plans for aligned TA, contributes to the QA strategy and through collaboration with stakeholders and our Research & Development Divisions QA TA Heads, refines and adjusts strategies and plans as needed. Identifies areas of greatest risk, through intelligence gathering (e.g., data trends, identified quality issues, regulatory intelligence), to proactively and accurately address and complete risk based QA assessments and influence the implementation of robust mitigation strategies. Lead and manage a range of GCP and/or Good Pharmacovigilance Practice (GPVP) audits, including complex audits (i.e., directed, for-cause), for a given program, across a program, therapeutic area or region. Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate, to provide Good Clinical Practice, Pharmacovigilance and QA expertise. Actively participate in Significant Quality Issue management, including assessment of potential root causes and remediation (corrective and preventative actions). Develops and enhances QA procedures, guidance documents and audit tools to ensure consistent global QA practices. Ensures rapid communication of QA issues including potential misconduct or issues of significant deviation within project/products to appropriate leaders and colleagues. Provides inspection management support as needed. Manage personnel or assist with the management of personnel and planning functional group activities to achieve functional area and/or departmental objectives, as applicable. Provides guidance and collaborates with QA Specialists, as appropriate, to assure adequate audit focus and timely knowledge transfer. Provides training and mentorship to less experienced members of our Research & Development Divisions QA. A Bachelor's degree in a related field with a minimum of 8 years of experience in GCP Quality/Auditing focused role. NOTICE FOR INTERNAL APPLICANTS In 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. GRACSJOBS 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 (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld) Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld) US 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 (https://survey.sogosurvey.com/r/aCdfqL) 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. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf) EEOC GINA Supplement 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 anothers thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/) U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote. Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidates relevant skills, experience, and education. Expected salary range: $164,800.00 - $259,400.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) . 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. 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