Sterility Manager

Job Description

An opportunity has arisen for a Sterility Testing Laboratory Manager in the Quality Control area within a pharmaceutical industry environment under GMP standards. This position will lead and ensure the comprehensive operation of the sterility testing and associated microbiology laboratory, guaranteeing reliable, timely results in compliance with Good Manufacturing Practices (GMP), pharmacopeias, and internal procedures.

The role will manage the resources, facilities, systems, and continuous improvement necessary to optimize the laboratory's status. Its scope includes sterility testing via membrane filtration and direct inoculation; reading, interpretation, and documentation of results; and management of personnel, capacity planning, materials, culture media, reagents, strains, equipment, and classified areas. It requires regular presence in laboratory areas and, where applicable, access to classified zones in accordance with gowning and qualification requirements. It may require availability to respond to critical incidents, audits, inspections, or operational needs outside of regular hours.

What you will do

You will contribute energy, knowledge, innovation, and leadership to carry out the following:

• Ensure GMP compliance and quality governance: execute activities in accordance with GMP, current pharmacopeias, marketing authorizations, and internal procedures; maintain the laboratory's permanent readiness for audits and inspections; lead the response to and closure of observations; and plan, prioritize, and supervise sample receipt, test execution, incubation, readings, data review, and result issuance within agreed timelines.

• Manage laboratory controls and operational continuity: establish controls for culture media, reagents, strains, materials, and consumables, including receipt, release, growth promotion, storage, expiration, and inventory; manage capacity and operational continuity, anticipating workloads, constraints, maintenance, and contingencies.

• Ensure facilities, environmental control, and contamination prevention: guarantee that testing is performed under appropriate aseptic conditions and that the design, flow of personnel and materials, cleaning, and disinfection reduce the risk of contamination; supervise the environmental and personnel monitoring program, its limits, alerts, actions, trends, and responses to excursions.

• Manage results, deviations, investigations, methods, and equipment: evaluate and immediately escalate events involving positive, atypical, or out-of-specification results; lead or supervise scientifically sound investigations into sterility failures, deviations, environmental excursions, and laboratory errors; ensure the transfer, verification, validation, or suitability of methods before routine use and maintain their validated status; ensure the qualification, calibration, preventive maintenance, and breakdown management of equipment and computerized systems.

• Guarantee data integrity, change management, and continuous improvement: ensure that electronic records meet requirements for data integrity, access, traceability, review, and retention; evaluate and approve, according to authority, changes in methods, equipment, facilities, systems, suppliers, materials, and monitoring programs before implementation; drive simplification, digitalization, automation, and new technologies without compromising compliance or microbiological control.

• Lead people, safety, biosafety, and sustainability: define the team structure, assign responsibilities, and ensure sufficient capacity for the workload and criticality of operations; select, train, qualify, and requalify personnel in aseptic technique, gowning, methods, safety, GMP, and data integrity; set objectives, monitor performance, develop capabilities, and foster leadership, collaboration, and individual accountability; ensure compliance with occupational safety, biosafety, industrial hygiene, and biological waste management requirements; promote safe practices and incident reporting.

What skills you will need

To be successful in this role, you must have:

• University degree in Microbiology, Biology, Pharmacy, Biotechnology, Biochemistry, or a related scientific discipline with relevant experience in a pharmaceutical microbiology laboratory under GMP.

• Demonstrated experience in team leadership, operational planning, investigations, and quality decision-making.

• Solid knowledge of aseptic technique, classified facilities, environmental monitoring, compendial methods, validation, data integrity, and risk management.

• Ability to communicate effectively in Spanish and English in a technical and regulated environment. At least equivalent to a B2 level.

• Visible leadership and people development; clear communication, influence, and cross-functional collaboration.

• Rigor, attention to detail, and documentation discipline.

• Root cause analysis and structured problem-solving.

• Planning, prioritization, and resource management, with the ability to manage pressure, ambiguity, and critical situations.

• Results orientation and continuous improvement. Experience in regulatory inspections, isolators, LIMS systems, microbial identification, and continuous improvement will be valued.

Why join us?

As a company, we are committed to keeping the patient at the center of everything we do and to seeking solutions and treatments for some of the world's most complex health needs.

We are proud to be a company that values bringing together diverse, talented, and committed people. The fastest way to drive innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to contribute your knowledge and leadership in a technical, regulated, and continuous improvement environment, apply today.

Required Skills:

Aseptic Handling, Biopharmaceuticals, cGMP Regulations, GMP Laboratory, Laboratory Operations, Manufacturing Quality Control, Microbiology, Pharmaceutical Quality Control (QC), Quality Systems Compliance, Root Cause Analysis (RCA)

Preferred Skills:

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Current Contingent Workers apply HERE

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

09/3/2026

*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.