Global Inspection Lead – Remote

Job Description

Core accountabilities and responsibilities, include:

Overarching Responsibilities on inspections:

Develops, updates, and maintains GCP inspection procedures and guidelines within GCTO.

Collaborates with Head of CQO and CQOL-Inspection & Enterprise Management to ensure the ongoing development and mentoring of CQOMs with respect to inspection management capabilities. Accountable for driving alignment and ensuring consistency in implementation of inspection management processes across GCTO.

Contributes to the development and / or revision of our companys policies, SOPs and training materials. Identifies industry best practices and leads knowledge management regarding important regulatory developments.

Leads/co-leads and acts as advisor/consultant for any of our companys sponsor inspection worldwide (HQ and country office).

Collaborates within GCTO and our Research & Development Division(e.g. CI, MAP, QA) to analyze inspection data to identify emerging signals, trends and risks and provides feedback to management as appropriate.

Directs and oversees the overall strategy for management/support of global GCP inspections to ensure that all phases of Health Authority/Regulatory inspections (i.e., notification, pre-inspection preparation activities, inspection liaison activities during the inspection, development and approval of the inspection response, tracking of submissions to the Health Authorities, and implementation of CAPA Plan) are handled consistently, professionally and proactively and result in outcomes that demonstrate the Company’s commitment to regulatory compliance.

Accountable for development and implementation of a proactive inspection communication and education strategy across GCD. This may include, but not be limited to, individual presentations, development of educational programs, facilitating our Research & Development Division course development, enterprise-level communication strategies, etc.

Ensures that a cross-functional Inspection Hypercare Team (IHT) is fully informed and capable of supporting any Health Authority inspection, worldwide.

Oversees the global inspection database/system that tracks all Health Authority submissions and inspections, worldwide.

Provides periodic reports/updates to senior management as directed by the CQOL- Inspection & Enterprise Management, related to regulatory agency inspections.

Act as the Quality Management subject matter expert and primary point of contact for all relevant functional areas on Inspection Management.

Escalates potentially significant inspection issues/observations to our companysSenior Management.

Oversees the development and maintenance of tools for use in managing regulatory inspections.

Reviews audit plans/reports for awareness and mitigation of potential inspectional exposure.

CAPA Management Support:

Ensures that all actions and commitments related to inspections are implemented in a timely manner. Maintains documented evidence supporting completion of all regulatory commitments.

Leadership/People Management activities:

Provides leadership, support and guidance to CQO colleagues assigned to inspections.

Works with management, peers and functional leadership to ensure appropriate resourcing for future inspections.

In collaboration with the Head, CQO and CQOLs, prepares others to assume new or increased responsibilities regarding regulatory inspections by providing learning and development opportunities.

Routine quality improvement activities:

Maintains an in-depth knowledge of clinical development and inspection-related issues and acts as an expert on international GCP requirements / inspection trends and developments.

Identifies inspection risks that may influence global quality strategy/initiatives.

Leads and supports remediation activities and process improvement initiatives as needed.

Liaises with our Research & Development Division QA to monitor trends from audits and may contribute to responses to audit observations regarding GCTO global processes.

Participates in and represent our company in external GCP working groups.

Maintains an expert knowledge of GCP, including current and emerging global guidelines and regulations, and engages in appropriate activities to influence the regulatory environment.

Minimum education required:

Bachelor’s Degree or equivalent in relevant health care area.

Required experience and skills:

Minimum of 12 years of relevant experience in clinical research including at least 8 years of direct experience with managing worldwide Health Authority inspections (e.g. FDA, EMA, MHRA, ANVISA, etc.), conducting both sponsor as well as site audits, direct field monitoring experience, with a demonstrated record of accomplishments.

Deep knowledge and understanding of Clinical Development Programs, Clinical Trial processes as well as quality management systems and quality control tools is required.

Direct knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.

Experience with delivering effective CAPA management solutions.

Demonstrated teaching and coaching capabilities, and experience as a mentor.

Superior oral and written communication skills in an international environment.

Well versed in risk-based approaches to inspection preparation/management.

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 of our Research & Development Division.

Able to act urgently for worldwide Health Agency 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.

#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/task/1422$6687.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/2022-10/22-088EEOCKnowYourRights1020.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:

$164,800.00 – $259,400.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. 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

Shift:

1st – Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date:

10/17/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date: 10/17/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R315371