Sr Manager, QA Operations

Sr Manager, QA Operations

Location: Canton, MA, US, 02021 Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

JOB SUMMARY

The Senior Manager, Quality Assurance Operations provides senior leadership and oversight of GMP Quality Assurance Operations at a vaccine Drug Substance manufacturing site, ensuring compliant execution of manufacturing activities and effective implementation of site quality systems in alignment with Site Quality Management expectations and global Quality standards. This role is accountable for real time QA oversight of manufacturing operations, lifecycle management of deviations, CAPAs, change controls, validation activities, and risk management, while operating as a key Quality decision-maker independent of Production, consistent with CGMP requirements. The position partners closely with QA Compliance and Supplier Quality, Quality Control, and Site Quality Management to ensure effective inspection readiness, audit support, risk escalation, and Quality Management Review (QMR) execution. The Sr. Manager supports internal and external projects, including technical transfers, supplier and partner interactions, and network initiatives, and is expected to cross train within the Quality Unit to ensure continuity of critical quality responsibilities. This role directly contributes to sustaining a state of control, regulatory confidence, and a strong quality culture across site operations.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Quality Operations Oversight

Provide senior QA oversight for GMP manufacturing operations, ensuring controls are implemented and executed in accordance with approved procedures and regulatory requirements. Maintain robust QA presence on the floor, supporting real time decision making, logbook review, batch documentation review, and issue resolution. Ensure Quality remains independent of production while enabling compliant execution.

Quality Systems Execution

Lead and oversee Deviations, CAPAs, Change Controls, Effectiveness Checks, and other site quality systems in accordance with SOP040945 and global procedures. Ensure timely, high quality investigations using sound root cause analysis and risk-based decision making. Review and approve complex investigations, including manufacturing deviations, OOS/OOT events, and excursions.

Risk Management & State of Control

Apply Quality Risk Management (ICH Q9) principles to assess, escalate, and mitigate quality and compliance risks. Support site and corporate Quality Risk assessments and ensure alignment with Site Quality Management expectations. Identify adverse trends and partner with QA Compliance to ensure appropriate escalation to senior management.

Validation & Lifecycle Oversight

Provide QA oversight and approval for qualification and validation protocols, reports, and deviations for facilities, utilities, equipment, processes, QC methods, and computerized systems. Ensure validation activities align with regulatory expectations and site control strategy.

Inspection Readiness & Audit Support

Support internal audits and regulatory inspections by ensuring QA Operations processes, records, and personnel are inspection ready. Participate as a Subject Matter Expert during regulatory inspections and audits, supporting responses and remediation activities in partnership with QA Compliance. Ensure operational readiness for FDA (CBER), global health authorities, and partner audits.

Quality Metrics & Management Review

Develop, trend, and present Key Performance Indicators (KPIs) supporting Quality Management Review (QMR). Provide operational quality insights to support assessment of process performance, product quality trends, and state of control. Communicate quality performance to site and corporate Quality leadership.

People Leadership & Organizational Resilience

Lead, coach, and develop QA Operations personnel, ensuring proper training, qualification, and performance management. Promote cross-training within the Quality Unit to support continuity of quality responsibilities. Foster a culture of accountability, engagement, and continuous improvement.

Projects, Technology Transfer & Partnerships

Provide QA Operations leadership for technology transfer activities, lifecycle changes, and introduction of new or modified processes. Support internal and external partnerships by ensuring Quality requirements are integrated into execution and risk is appropriately managed. Collaborate with Supplier Quality and Compliance functions to ensure operational impacts from supplier or partner activities are properly assessed.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.

Education Bachelor's degree in Biological Sciences, Chemistry, Engineering, or a related scientific discipline required. Advanced degree preferred.

Experience 810+ years of progressive GMP Quality experience within pharmaceutical or biotechnology manufacturing. Demonstrated experience supporting biologics or vaccine Drug Substance operations. Proven leadership of QA Operations and Quality Systems in a regulated manufacturing environment. Prior experience supporting regulatory inspections, internal audits, and inspection readiness activities. Experience supporting technical transfers, validation activities, and cross functional quality initiatives. Previous people leadership experience is required.

Skills & Competencies Strong working knowledge of CGMP regulations, industry guidance (FDA, EMA, ICH), and phase-appropriate quality expectations. Demonstrated ability to assess risk, interpret complex data, and make sound quality decisions in a fast-paced manufacturing environment. Excellent written and verbal communication skills, including the ability to present complex quality topics to senior leadership. Influential leader capable of operating effectively in a cross-functional, matrixed organization. Ability to critically review and approve SOPs, validation documents, investigations, protocols, and regulatory responses. Strong organizational skills with the ability to manage multiple priorities simultaneously. Proficiency with MS Office applications (Word, Excel, PowerPoint) and electronic quality management systems (eQMS).

U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $171,500 to $207,500 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: (*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy. Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.