Senior Manager, Quality Assurance Shop Floor
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
I: JOB SUMMARY
The Sr. Quality Assurance Manager, On the Floor (OTF) provides quality oversight and management for the Bayview Quality OTF functions to ensure patient safety and compliance with FDA and other applicable health authority requirements. In addition, the Sr. QA Manager provides input for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities. Finally, the QA Manager fosters a culture of quality and compliance through effective leadership and strict adherence to Emergent core values.
II: ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Develop the QA OTF team and management structure by hiring qualified external talent along with internal resources.
• Develop an onboarding process to enable swift but thorough inclusion of new employees to the shop floor team
• Lead the QA OTF team ensuring alignment with client expectations and on-time batch delivery according to plan, including the management of the team to provide 24/7 coverage of manufacturing operations.
• Develop, implement, and optimize quality processes to achieve site objectives. Build and define respective roles and responsibilities within the QA OTF team and execute in a manner to gain efficiencies in support of site operations.
• Must have a strong working knowledge of cGMPs as they relate to Batch Production Record adherence, Good Documentation Practices, and compliant manufacturing of GMP materials. Must also possess the knowledge to support deviation investigation/resolution and generation/implementation of identified CAPAs.
• Exhibit appropriate computer skills and understanding of SAP or similar electronic inventory management system.
• Serve as a member of the Bayview Quality Operations management team. Quality representative to assess real-time potential deviation impact, investigation need and thoroughness of required investigations.
• Maintain the QA OTF program in an inspection ready state by regulatory agencies and clients.
• Align with and influence business partners to ensure cGMP compliance
• Lead daily operational initiatives. The successful candidate will have a proven track record of operational execution while retaining high quality of the deliverables.
• Work effectively with various Site functions to align systems across the site.
• Participate in interdepartmental and operational excellence initiatives. Interact with other functional areas to define and execute project requirements and objectives and maintain compliance across the site.
• Candidate must have track record of working effectively in teams to resolve issues and elevate as appropriate. Ability to prioritize and multitask necessary.
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 managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
III: MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor’s Degree in Biology, Chemistry, Engineering, or related fields
• A minimum of five (10) years of cGMP Quality experience (QA/QC/Validation)
• A minimum of two (5) years in roles of increasing management or project management responsibility in a biopharmaceutical manufacturing environment
• Strong communication skills: oral/written and listening
• Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability
• Interpersonal skills: team building, consensus building, conflict resolution
IV: PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.
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.