Sr. Manager, QAPQ

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

Job Summary

The Sr. Manager of Quality Assurance Product Quality (Sr. Manager QAPQ) will be responsible for the Quality Assurance Product Quality (QAPQ) and Quality Assurance Document Control (QADC) operations at the Emergent Canton site. The Sr. Manger QAPQ provides Product Quality support for all aspects of process development, commercial manufacturing, testing and disposition of product, and materials and components. This person is the owner of the Batch Record review and batch disposition process at the site, the review and disposition of Raw Materials and Components, Right First Time (RFT) metrics, complaints and investigations related to Adverse Events, etc. This position will also be responsible for the Documentation Control process at the site (i.e. EDMS, approval and issuance of records, archival, upkeep and audit readiness of archive rooms, etc.). This is an on-site position.

Responsibilites • SME and owner of the review/approval process of batch records (i.e. commercial batches, Aseptic simulation records, Engineering and Development records)• SME and lead the disposition of Raw Materials, Components and Vaccine Drug Substance/Drug Product following Corporate standards, internal procedures and local and/or international regulations• Lead the Quality Assurance Document Control (QADC) department at the site• Own and lead the QA shop floor program (Quality Oversight, logbook review, solve issues real time with operations personnel, etc.)• Oversee the QA work order assessment process in SAP• Own the complaint investigation program at the site (generation, investigation and approval)• Support the Adverse Event (AE) investigation program• Manage the generation, execution and technical review of data and documentation, ensuring that they are maintained in compliance with FDA regulations, global regulations and Emergent internal directives.• Establish, track and present Quality Metrics (i.e. batch acceptance rate, complaints, etc.) to support Quality Management Review. • Support site and global initiatives as needed

Education, Experience & Skills• Bachelor's degree in Biological Science or similar science• Minimum of 8 years of pharmaceutical cGMP Quality experience with increasing responsibilities. • Previous experience in management of Quality Assurance.• Previous people leadership experience is required • Previous experience with batch record review and batch disposition is required• Previous experience working with FDA (CBER) and participating in regulatory agency inspections• Must have skills for the critical assessment of SOP's, investigations, and project protocols for content that will meet compliance requirements.• Must have excellent verbal and written communication skills and the ability to successfully manage without authority in a cross-functional matrixed environment. • Must be able to create, manage and report metrics• Must be able to critically evaluate data summaries and conclusions. • Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required• Must possess strong cGMP knowledge across Quality and Compliance functions• Must have competence of cGMPs, 21CFR210, 211, 600, USP-NF, and Aseptic Processing Guidelines

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder no matter what
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • Every person at Emergent is engaged and accountable for delivering on our commitments.
• Break through thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.