"Alerted.org

Job Description

Primary Activities:

+ Oversee the Compliance, Remediation, and Support (CRS) team within Global Quality Compliance Support.

+ Provide compliance leadership and direction to our company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients (API), biologics and vaccine drug substances, finished products, and combination products.

+ Oversee quality systems pertaining to health authority inspections, inspection and audit CAPA, site internal audit programs, and GMP-related regulatory communications.

+ Oversee program to ensure CRS support to sites before, during, and after health authority inspections and provide enhanced support for inspections deemed to be high risk

+ Oversee program to ensure CAPA are effectively implemented

+ Oversee program to support remediation of significant GMP compliance risks within the network

+ Oversee health authority reporting program to ensure compliance to global regulatory reporting requirements (e.g., Field Alert Reports (FARs), Biological Deviation Reports (BPDRs), Defective Product Reports (DPRs))

+ Support audit program by identifying audit targets and help develop protocols for targeted assessments

+ Support network observation sharing program by ensuring that appropriate global actions are taken in response to inspectional findings at network sites

+ Support external advocacy initiatives and internal knowledge management initiatives via active participation in industry organizations such as PDA, PQRI, PhRMA, ISPE etc.

Education Minimum Requirement:

Required Experience and Skills:

+ A minimum of 10 years of quality, operational or technical experience within the pharmaceutical, biopharmaceutical, vaccine, or medical device industry

+ Expert knowledge of GMP requirements for multiple regulatory agencies

+ Ability to accurately interpret and apply regulatory expectations for a robust and compliant QMS

+ Experience in health authority inspections, a compliance decision-making role preferred

+ Experience assessing remediation plans

+ Drive Results – set clear performance standards, overcome obstacles; accountable for actions and achieve results

+ Make Rapid, Disciplined Decisions – demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions

+ Act with Courage and Candor – ability and willingness to advocate for compliance position using objective evidence, escalates issues and decisions, as appropriate

+ Foster Collaboration – ability to influence, facilitate groups with diverse perspectives, bring teams to consensus/alignment

+ Build Talent – build talent with the capabilities necessary to succeed in our markets; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary

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.

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 (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 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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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, Monday - 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 salary range for this role is

$227,300.00 - $357,900.00

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

50%

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Biological Sciences, Biopharmaceuticals, Business, cGMP Compliance, Combination Products, Cross-Cultural Awareness, Customer-Focused, Data Analysis, Detail-Oriented, Ethical Standards, GMP Compliance, Mentoring Staff, Microbiology, People Leadership, Pharmaceutical Management, Pharmaceutical Manufacturing, Process Improvements, Quality Management Systems (QMS), Regulatory Inspections, Regulatory Reporting, Sterile Processing

Preferred Skills:

Job Posting End Date:

06/12/2025

*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:** R352925