Senior Manager, Quality, Protein XI

POSITION SUMMARY:

This position is responsible for providing senior operational leadership for the Protein XI (PXI) Quality Control organization and will lead the group following the planning and execution of laboratory space, equipment qualification, and ISO-compliant procedures required to ensure operational readiness, regulatory compliance, and sustained operations as PXI transitions into manufacturing and routine QC testing. The incumbent leads cross-functional activities to establish inspection-ready facilities, qualified equipment, and compliant procedures to support successful technical transfer and product launch. This role supervises the work of others directly and across interdisciplinary teams and provides operational leadership to support department and company objectives.

DUTIES AND RESPONSIBILITIES:

* Provide overall leadership and accountability for planning and execution of QC laboratory space readiness to support PXI testing, including layout, workflows, utilities, and environmental requirements.

* Serve as the primary QC authority partnering with Facilities, Engineering, EHS, and Validation to ensure laboratory spaces meet safety and regulatory requirements.

* Own selection, installation, qualification, and lifecycle strategy for QC laboratory equipment.

* Approve and ensure execution of IQ/OQ/PQ for critical QC equipment and systems.

* Own development, implementation, and governance of ISO-compliant Standard Operating Procedures (SOPs), work instructions, and controlled forms.

* Accountable for QC readiness for technical transfer of PXI assays from development into QC.

* Lead and govern cross-functional transfer activities with Process Development, Manufacturing, Validation, Regulatory, and Quality Assurance.

* Provide senior operational leadership for the established PXI QC organization to ensure operational readiness, regulatory compliance, and sustained testing operations.

* Direct and manage staff supporting PXI QC operations.

* Establish strategy and approve plans for staffing, training, and organizational development aligned with PXI manufacturing growth.

* Own performance management for the organization, including goal setting, accountability, coaching, and succession planning.

* Establish and monitor KPIs for readiness, compliance, quality, and testing performance.

* Own risk management for QC operations, including identification, mitigation, and escalation of compliance and readiness risks.

* Sponsor and approve continuous improvement and inspection readiness initiatives.

* Serve as senior QC representative on PXI governance, launch readiness, and operations leadership forums.

* Ensure compliance with laboratory safety practices and company safety policies.

* Respond to emergency alerts and/or calls from equipment and facility monitoring systems concerning laboratory equipment and environmental laboratory failures during regular work hours, evenings, weekends, and holidays. This includes responding promptly to unit failures and transferring materials to alternate storage (e.g., CTUs) to protect inventory integrity.

EXPERIENCE AND QUALIFICATIONS:

* Bachelor's degree and 8 years' experience in relevant field is required.

o Additional education may be substituted for experience.

* Three years of management experience is required.

* Experience with quality document systems in a regulated environment is required.

* ASQ certification strongly preferred.

* Experience with computer languages and analytical platforms (e.g., R, Python, Visual Studio-based tools, or equivalent) to build models; automate analyses, and support method performance and trending, preferred.

KNOWLEDGE, SKILLS AND ABILITIES:

* Knowledge of Next-Generation Sequencing (NGS) or other sequencing platforms, with the ability to translate sequencing workflows, data review, and troubleshooting into a Quality Control environment.

* Ability to handle, analyze, and troubleshoot large and complex data sets, including use of statistical and computational tools to assess data quality, identify trends, and resolve atypical results.

* Knowledge of ISO quality systems and laboratory compliance requirements.

* Thorough understanding of analytical testing in a regulated QC environment, including ELISA and PCR.

* Strong leadership skills with demonstrated knowledge of staff management practices and the ability to establish accountabilities and manage performance to achieve results.

* Excellent communication skills with the ability to organize, present, and articulate ideas both verbally and in writing.

* Logical problem-solving skills and the ability to manage complex projects and meet timely deadlines.

* Demonstrated ability to drive continuous improvement and operational excellence.

* Demonstrated ability to work and manage others independently.

* Ability to work effectively in a fast-paced, high-energy, demanding and deadline driven environment.

* Excellent interpersonal skills to interact effectively with individuals at all levels of the company.

* Ability to build and foster relationships.

* Proficiency in MS Office suite and electronic quality systems.

* Ability to participate in on-call rotation and respond to critical incidents outside regular business hours.

PHYSICAL DEMANDS:

* This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job and move about the office.

* This position requires travel and work across multiple company work sites as needed.

WORK ENVIRONMENT:

* Standard office environment.

* Laboratory environment working with chemical reagents.

COMPENSATION SUMMARY:

The annual base salary for this position ranges from $101,400 to $154,700. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.

BENEFITS SUMMARY:

At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.

EEO/AA STATEMENT:

MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please click on the following link: https://www.mesoscale.com/en/our_company/careers/equal_employment_opportunity_statement.

Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.