Job Description
CORE Accountabilities and Responsibilities:
Overarching Responsibilities:
It is business critical that our company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead (CQOL) and Head of CQO, the ACQOM is responsible for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities.
The ACQOM will assist with headquarters clinical quality operations support of clinical trial teams within the assigned therapeutic area, to proactively embed quality into our company sponsored trials, ensure adequate supplier oversight and address any quality issues as needed.
The incumbent will support the development of quality plans to implement quality by design within clinical development programs, using a risk-based approach.
The incumbent will assist with the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.
Clinical Trial Team, Research Portfolio and Enterprise Support.
Develop the necessary skills to independently support assigned Clinical Trial Teams and assist with implementation of Quality by Design.
Develop the ability to lead Inspection Support Teams (IST) with the aim of ensuring that, at all stages, the Clinical Trial Team (CTT) maintains ongoing inspection readiness.
Support mergers and acquisitions of clinical research products and organizations to ensure comprehensive knowledge transfer, risk management and inspection readiness.
Participate in and support individual Significant Quality Issues (SQI) with the aim of developing the necessary skills to independently and autonomously represent CQO.
Train and develop the ability to be able to perform study quality control activities in order to identify emerging risks and process gaps at the study level.
Be responsible, under the guidance of the CQOL, for performing periodic reviews of quality folders within shared CTT TeamSpaces for accuracy and completeness.
Risk Management.
The ACQOM will become knowledgeable about and proficient in the use of Risk Management organizations methodologies, tools and processes: e.g., Risk Evaluation and Adaptive Integrated Monitoring (REAIM), Risk Assessment and Categorization Tool (RACT), Xcellerate system.
Be responsible for the periodic review of critical data and processes (CD&P) at key stages of the clinical trial protocol lifecycle against the Risk Assessment and Categorization Tool and Risk and Issue Management (RIM) module.
Regulatory Inspections.
The ACQOM will, under the guidance of CQOL and Sr.CQOM, develop the knowledge and skills to support non-sponsor (e.g. clinical investigator site) and sponsor inspections.
Develop the knowledge and skills to be able to track and manage Corrective and Preventive Actions (CAPA) and associated regulatory commitments to completion, ensuring that key inspection documentation is maintained at all times.
The ACQOM will, as required by CQOL, perform quality control reviews of key inspection document repositories (Documentum/ Veeva Quality Management System) to ensure presence and completeness of all key and essential documents (e.g., inspection reports, responses, internal CAPA plan, regulatory communication, CAPA evidence).
Participate in, support and develop knowledge of “lessons learned” activities with the aim of being able to independently lead and manage them.
Assist experienced CQO colleagues with development of inspection responses.
The ACQOM will, under the guidance of the CQOL, GISL and GIC, conduct reviews of inspection outcomes for signals and trends.
Quality Assurance Audits.
Develop knowledge and skills to support a variety of Quality Assurance audits, including: audit facilitation and CTT support, root cause analysis for any applicable observations, development of responses, CAPA management and tracking.
Assist CQOM with logistics and project management of CAPA development, i.e., meeting scheduling, discussion notes, follow up actions.
Third Party Suppliers.
The ACQOM will develop knowledge of supplier oversight processes and requirements in order to be able to effectively support Clinical Trial Teams and global functional lines in ensuring adequate sponsor oversight. This will include, but not be limited to, development and maintenance of quality agreements, issue resolution, management of performance indicators, assistance with audits and inspections, risk management and data signals and trends.
Assist CTT with root cause analysis of all quality issues and develop/manage CAPA.
CQO Infrastructure and Process Innovation.
The ACQOM will contribute to the ongoing development of CQO infrastructure and process innovation. In particular the ACQOM will develop an advanced understanding of GCP worldwide, including; ICH, FDA Code of Federal Regulations, EMA Clinical Trial Regulation
Minimum required education :
Required experience and skills:
Minimum of 3 years of relevant experience in the pharmaceutical industry and/or clinical research. Knowledge of quality and risk management methodologies is desirable.
Knowledge and understanding of clinical development programs and clinical trial processes.
Knowledge of Quality Management Systems (QMS).
Knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
Prior experience of root cause analysis and CAPA management.
Superior oral and written communication skills in an international environment.
Excellent project management and organizational skills.
Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
Ability to lead cross-functional teams of business professionals within and outside our Research & Development Division.
Able to act urgently for worldwide health authority inspection matters.
Ability to analyze, interpret and solve complex problems.
Ability to think strategically and objectively and with creativity and innovation.
Ability to proficiently interact with all levels of specialists & management and exert influence to achieve results.
Ability to identify and summarize the key issues from audits and inspections and to develop and deliver lessons learned.
ResearchDivisionGCTO
#EligibleforERP
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.
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
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
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.
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 candidate’s relevant skills, experience, and education.
Expected salary range:
$107,600.00 – $169,400.00
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. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote Work
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Requisition ID: R272480
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