Associate Global Inspection Coordinator, Remote

Job Description

Under the guidance of the Head, CQO and Clinical Quality Operations Lead – Inspection & Enteprise Management (IEM), the Associate Global Inspection Coordinator (AGIC) will manage the data associated with global inspections including; inspection notifications, tracking of inspection status, CAPA and regulatory commitments. The AGIC will develop processes and systems that facilitate effective management of these data, such as the inspection database, together with standardized and custom reporting tools and templates. The AGIC will collaborate with other QCI functions to analyze and report inspection metrics. They will support the Head, CQO and CQOL-IEM in development, implementation and management of future major submissions dashboards together with the prioritization and assignment of resources to inspection support and management activities within CQO and QCI. They will manage all definitive records of regulatory GCP inspections including, but not limited to; inspection notifications, information and document requests, inspection reports/outcomes (including translations), regulatory communications relating to an inspection (e.g. close out letters). The AGIC will liaise with other functions within CQO and QCI to assist with the management of Inspection Response Documents and CAPA plans.

CORE Accountabilities and Responsibilities, include but are not limited to:

Overarching Responsibilities:

• Manages the overall flow of inspection data from notification to close out of an inspection.
• Ensures that regular QC reviews are conducted within the Inspection Database to ensure accuracy and consistency of information.
• Ensures that timely updates are made within the QCI tracking system and that any overdue milestones are escalated to the Head, QCI and the Head, CQO.
• Ensures the timely communication of key inspection events to stakeholders (e.g.inspection notification, receipt of regulatory communication).
• Leads and actively participates in development of new technologies to enhance processes and management of information, including ongoing development, deployment and training of staff in the QMS system (Veeva QMS).
• Trains CQO and QCI personnel in use of QMS system and acts as point of contact and SME for ongoing process development and enhancement.
• Leads and manages development and enhancement of new/revised internal processes and guidance documents/work instructions.
• Supports global and regional initiatives as applicable such as, development of CQO information repositories, stakeholder interface portals, regional leadership metrics updates, SharePoint evolution.
• Implements and monitors a CQO inspection notification mailbox.
• Manages and maintains all definitive inspection records.
• Develops tools and templates for timely, consistent and accurate reporting of inspection metrics including, but not limited to; status dashboards, periodic reports and trends or changes in inspection data.
• Researches, identifies and deploys novel methodologies for enhanced reporting of data to senior stakeholders including signal/risk detection, heat maps, chronological trends.
• Independently develops and presents key inspection data to cross-functional stakeholders, e.g. GCD QCC, GCTO SLT, Compliance, our Research & Development Division QA, ,GRACS, GDMS.
• Collaborates with our Research & Development Division to compile and review quarterly update for Board of Directors and State of Quality Dashboard, including key inspection outcomes.
• Supports ongoing, global portfolio regulatory submission activities by compiling and reviewing key aspects of submissions requiring GCP inspection data.
• Assists the Head, CQO with the development, implementation and management of a process to collate data on key activities that could trigger an inspection (e.g. major submissions, cyclical re-inspection, and spontaneous regulatory communication).
• Assists other functions within QCI with inspection response processes and management of documentation including; Inspection Response Documents (IRD), CAPA plans and evidence that regulatory commitments have been met.

Other activities:

• Provides input into GCP Quality and Compliance Council regarding Health Authority inspections status and results, including escalation of overdue CAPA commitments.
• Supports the development of inspection metrics and lessons learned, as needed.
• Provides input to strengthen company programs/strategies (e.g. QCV, HQ QCP) with an aim to increase Inspection Readiness.
• Leads training and education of QCI personnel in new and emerging data analytics methodologies (e.g. power queries, data trending, enhanced visualizations).
• Assists Head, CQO with strategic prioritization of work within CQO and facilitates assignment of resources to specific tasks or projects.
• Leads and manages maintenance and assigning of QCI training curricula, and QCI MyLearning reporting needs; SME and primary point of contact for MyLearning QCI job codes and curricula (GCD Curriculum Team Lead for QCI).
• Develops, trains and oversees CQO business continuity resources for coverage of GIC role.
• Oversees temporary assignments tasked with CQO data management related activities.
• Manages and responds to requests to the Legacy Process Documentation Request Mailbox, as joint mailbox custodian with the GCD STDs steward.
• Actively identifies opportunities to enhance management of inspection information through use of new technologies, system and processes.

Education:

• Bachelor’s Degree or equivalent in relevant area

Experience:

• Experience in pharmaceutical industry, including relevant exposure to clinical operations, quality management and GCP Health Authority inspections.
• Knowledge and understanding of clinical development and clinical trial processes as well as quality management and control tools.

Skills:

• Superior oral and written communication skills in an international environment.
• Project management and organizational skills.
• Demonstrates 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
• Ability to analyze, interpret and solve complex problems.
• Ability to proficiently interact with all levels of specialists & management and exert influence to achieve results.
• Excellent understanding of AI, data management, metrics and systems are essential as well as ability to produce visual materials and tools.

elgibleforERP

clinicaltrialjobs

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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 if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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:R402252