GMP COMPLIANCE EXPERT

Job Description The Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company’s Global Quality Compliance Support organization.
The responsibility of this position crosses all Human & Animal Health operating units and requires extensive collaboration with manufacturing sites and global GMP SMEs.
Job Function.
serve as a subject matter expert for good manufacturing practices (GMP) for drug products, active pharmaceutical ingredients, biologics, vaccines, and devices support remediation activities and pre-approval inspection readiness activities provide expert guidance and assistance to our company’s manufacturing sites along with our contract manufacturing operations on GMP matters before, during, and after health authority inspections ensure CAPAs intended to address audit findings are effective and adequately implemented ensure new and developing global standards and procedures impacting manufacturing sites are fully compliant with international regulatory expectations serve as an SME for health authority reporting (e.
., FAR, BPDR, DPRs, MDRs) develop and use data analytics tools to assess compliance risk at sites support our company’s audit program by identifying audit targets and help develop protocols for targeted assessments actively participate in industry organizations such as, PDA, PQRI, PhRMA, ISPE, etc.
Minimum Education Requirement and Experience.
Bachelor of Science (B.
.) in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required with ten (10) years of quality, operational, or technical experience within the GMP regulated environment OR Master of Science (M.
.) in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required with eight (8) years of quality, operational, or technical experience within the GMP regulated environment OR Ph.
.
in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required with five (5) years of quality, operational, or technical experience within the GMP regulated environment Required Skills and Experience.
Able to travel up to 50% of the time Expert knowledge of GMPs and regulatory requirements and expectations Experience and exposure (not less than 5 years) in managing health authority inspections and communications in a pharmaceutical, biotechnology, or device manufacturing site    Strong familiarity with sterile manufacturing operations and compliance requirements for aseptic processing Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.
History of being accountable for actions and driving results Good judgment and logical thought processes in collecting and synthesizing relevant data and information to make independent and timely decisions Ability to communicate, influence, and escalate issues and decisions, as appropriate Expert knowledge of international GMPs/requirements of multiple regulatory agencies Preferred Skills and Experience.
A minimum of 15 years of quality, operational, or technical experience within the GMP regulated environment Experience working for a health authority/board of health as an inspector, investigator, product reviewer, compliance officer, or other GMP/regulatory role Strong background in data analytics Demonstrated ability to creatively use multiple methods of analysis to decipher large datasets, including text-based datasets (e.
., lists of compliance observations) Strong background and technical understanding of vaccines and/or biologics 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.
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.
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Hybrid Work Model Effective September , employees in office-based positions in the U.
.
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.
his 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.
$ 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.
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.
1st - Day Valid Driving License.
No Hazardous Material(s).
N/A Job Posting End Date.
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Requisition ID.
R