QA OPS Manager B79 Viral PCU Lead

Sanofi; Swiftwater (Monroe County); On-site; USD 110,000 - 160,000; Full time

Job summary

Sanofi in Swiftwater, PA is seeking a QA OPS Manager – B79 Viral PCU Lead to steer the quality assurance operations for the B79 Viral Manufacturing, B78 Seed Facility and QC Facility. You will lead a team of QA professionals, ensure GMP compliance, manage quality events, investigations, risk controls, and batch release activities to safeguard product quality throughout the lifecycle.

You will collaborate with manufacturing and QA partners, drive continuous improvement, deliver regulatory-ready

Qualifications

• Bachelor’s Degree in life sciences, engineering, or related technology degree is required.
• Minimum 5 years of QA experience in the pharmaceutical industry.
• Strong knowledge of GMP and QA principles.
• Ability to analyze complex data and identify trends and solutions.
• High accuracy and attention to detail in QA activities.
• Strong verbal and written communication for regulatory interactions.
• Ability to manage multiple projects and meet deadlines.
• Fluent in English.
• Knowledge of visual inspection principles preferred.

Responsibilities

• Ensure site activities comply with regulatory requirements and maintain licenses.
• Ensure GMP compliance and other relevant regulations.
• Oversee daily QA ops team activities aligned with goals and regulatory needs.
• Close quality events (deviations, CAPAs, PQR, change controls) promptly.
• Oversee investigations related to product quality for risk and impact assessment.
• Conduct regular production process audits to spot quality issues.
• Collaborate with production to maintain quality throughout lifecycle.
• Manage and resolve quality-related issues promptly and effectively.
• Train and manage QA operations team.
• Monitor quality performance metrics and implement corrective actions.
• Lead root cause analyses for quality incidents and preventive actions.
• Participate in internal and external audits and regulatory inspections.
• Develop and implement risk management strategies to mitigate issues.
• Foster a culture of quality and continuous improvement.
• Oversee batch record review and release processes per GMP.
• Review and approve batch records and related documentation.
• Ensure batch release activities comply with GMP.

Skills

Quality assurance

GMP

Data analysis

Attention to detail

Communication skills

Multi-project management

English fluency

Visual inspection knowledge

Education

Bachelor’s Degree in life sciences, engineering, or related technology degree

Job description

Job Title: QA OPS Manager B79 Viral PCU Lead

• Location: Swiftwater, PA

About the Job:

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as QA OPS Manager – B79 Viral PCU Lead within our Quality Assurance team, will be to lead and drive quality over the B79 Viral Manufacturing, B78 Seed Facility and QC Facility.

This role provides leadership and direction for quality oversight of the vaccine drug product manufacturing. This leadership role collaborates with a group of highly skilled and technical colleagues toward an inspiring mission of creating high-quality life-saving vaccines. The QA OPS Manager -B79 Viral PCU Lead will lead a team of quality professionals overseeing the B79 Viral Manufacturing, B78 Seed Facility and QC Facility.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

Main Responsibilities:

• Ensuring that all site activities are conducted in compliance with applicable regulatory requirements and that valid manufacturing licenses and product permissions are maintained
• Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations
• Overseeing the daily operations of the quality assurance team assigned, ensuring all activities align with company goals and regulatory requirements
• Ensuring the timely closure of quality events such as deviations, CAPAs, PQR, and change controls to maintain compliance and operational efficiency
• Overseeing all the investigations product-related (eg deviation, OOx) in their scope to ensure they are properly conducted, allowing appropriate risk assessment and product impact assessment
• Conducting regular audits of production processes to identify and address potential quality issues
• Collaborating with production to ensure quality standards are maintained throughout the product lifecycle
• Managing and resolving quality-related issues in a timely and effective manner
• Training and managing quality assurance operational team
• Monitoring and analyzing quality performance metrics, implementing corrective actions as needed
• Leading root cause analysis investigations for quality incidents and implementing preventive measures
• Participating in internal and external audits and regulatory inspections providing support and documentation
• Developing and implementing risk management strategies to mitigate potential quality issues
• Fostering a culture of quality and continuous improvement across the organization
• Overseeing the batch record review process for area within their scope, ensure compliance with regulatory requirements and company standards
• Reviewing and approving batch records and associated documentation
• Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)

Following key decisions (D,A,I):

• Establish and prioritize quality and compliance objectives for the site (D)
• Ensure the implementation and maintenance of robust quality systems, in line with global quality (D)
• Proactively implement remediation action from findings from internal and external audits related to quality issues (D)
• Advise on quality improvement initiatives and strategies (A)
• Escalate the issues when needed (I)
• Ensure the right level of training required for the team to perform routine tasks (D)
• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I)
• Advise on risk management strategies and plans (A)
• Advise on initiatives to promote a quality-focused culture (A)
• Approve documentation for batch disposition and update corresponding digital tool to allow release (D)

Benefits of working in this role:

• Be part of an inspiring mission to create life-saving vaccines
• Leading a skilled and motivated team of quality professionals
• The work environment is a highly collaborative and technical vaccine manufacturing operation on a beautiful park like campus.

About You:

Requirements and Qualifications:

• Bachelor’s Degree in life sciences, engineering, or related technology degree - required.
• Minimum 5 years of experience in quality assurance within the pharmaceutical industry.
• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles
• Ability to analyze complex data and identify trends, issues, and solutions
• High level of accuracy and attention to detail in all quality assurance activities
• Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
• Proficiency in identifying problems and implementing effective corrective actions
• Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards
• Fluent in English
• Knowledge of visual inspection principals and requirements preferred

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.