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Sr Manager, QA ComplianceEmergent Biosolutions • Canton, Ohio, United States
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Sr Manager, QA Compliance

Emergent Biosolutions
  • US
    Canton, Ohio, United States
  • US
    Canton, Ohio, United States
Postuler Maintenant

À propos

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 Sr. Manager, QA Compliance is a senior site Quality leader responsible for ensuring continuous GMP compliance, inspection readiness, and robust supplier quality oversight for a vaccine Drug Substance (DS) manufacturing site in Canton, MA. The role has primary accountability for internal audit programs, regulatory inspection preparedness and execution, and site-level implementation of global supplier quality and compliance strategies.
This position partners closely with Site Leadership, Global Process Owners (GPOs) of Quality Management Systems (QMS), Manufacturing, Supply Chain, MSAT, and Global Quality to ensure alignment with global standards, regulatory expectations (FDA/CBER and global health authorities), and industry best practices. The incumbent serves as a key member of Site Quality Management, providing independent quality oversight, risk-based decision making, and leadership to ensure reliable supply of compliant vaccine drug substance.
ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Own and lead site GMP audit readiness, including internal (self-inspections), supplier, corporate, client, and regulatory inspections, ensuring a sustained state of inspection readiness at all times.
Manage and execute the site Internal Audit Program, including risk-based audit planning, auditor qualification, audit execution, reporting, escalation of critical findings, and effectiveness checks.
Lead regulatory inspection preparedness, hosting, and response activities for FDA (CBER) and other global health authorities; ensure timely, thorough, and compliant responses to inspection observations.
Provide site leadership for Supplier Quality Management in alignment with global GxP Supplier Quality programs, including supplier qualification, performance monitoring, supplier audits, Supplier Change Notifications (SCNs), and Supplier Corrective Action Requests (SCARs).
Partner with Global Process Owners (GPOs) to deploy, sustain, and continuously improve global Quality Management Systems related to compliance, audits, supplier quality, self-assessments, and Quality Risk Management.
Ensure Quality Agreements are established, maintained, and implemented for GMP suppliers and service providers in accordance with global procedures.
Serve as the site Subject Matter Expert for GMP compliance, audit execution, inspection readiness, and supplier quality-related matters, providing clear interpretation of regulatory and internal requirements.
Oversee Quality Management Reviews (QMRs) related to compliance and supplier performance, including preparation, data analysis, trending, and presentation of key quality metrics to Site Leadership.
Provide quality oversight and guidance to site deviation investigations, CAPAs, and change controls with potential compliance or supplier quality impact, ensuring risk-based, timely, and effective resolution.
Ensure alignment of raw material specifications, Approved Supplier Lists (ASL), and supplier documentation with regulatory filings and global quality standards.
Lead, develop, and mentor Quality Compliance and Supplier Quality personnel, fostering a strong quality culture, inspection readiness mindset, and continuous improvement.
Drive continuous improvement initiatives focused on strengthening compliance, simplifying processes, enhancing inspection outcomes, and improving supplier performance and reliability.
Ensure effective communication and escalation of quality risks and compliance issues to Site Leadership and Global Quality Management, maintaining Quality Unit independence.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
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.
Bachelor's degree in Biological Sciences, Chemistry, Engineering, or a related scientific discipline required; advanced degree (Master's or PhD) preferred.
Minimum of 8-10 years of progressive GMP Quality experience within biopharmaceutical, vaccine, or sterile drug substance manufacturing environments.
Demonstrated experience leading GMP compliance programs, internal audits, regulatory inspections, and supplier quality management for FDA-regulated products (CBER experience strongly preferred).
Proven people leadership experience, including direct management, coaching, and development of Quality professionals.
In-depth knowledge of U.S. and global GMP regulations and guidelines, including 21 CFR Parts 210, 211, 600, ICH Q7, Q9, Q10, and applicable FDA guidance.
Strong working knowledge of supplier qualification, auditing, quality agreements, and supplier performance management within a global supply chain.
Demonstrated ability to operate independently within the Quality Unit, exercising sound judgment, risk-based decision making, and appropriate escalation.
Excellent written and verbal communication skills, with the ability to interface effectively with regulatory agencies, senior leadership, and cross-functional teams.
Strong analytical skills and ability to evaluate complex data, compliance trends, and quality metrics to support management decision-making.
Experience working effectively in a matrixed, global organization and influencing without direct authority.
Proficiency with electronic QMS, document management systems (EDMS), audit management tools, and standard business applications (e.g., MS Office).
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: https://www.emergentbiosolutions.com/careers/life-at-emergent
*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.
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  • Canton, Ohio, United States

Compétences linguistiques

  • English
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