Sr Manager, Quality Assurance Operations
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.
The Sr. Manager of QA Operations is responsible for day-to-day management of personnel and Quality Systems (e.g., Deviations, CAPAs, Effectiveness Checks, Change Controls, validation oversight, etc.) within the Quality Operations group by networking with internal stakeholders to positively influence the compliance health of the company. This is a key role which contributes to the continuous improvement of Quality and Compliance at the Canton site.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Accountable and Subject Matter Expert (SME) for Quality Management Systems (QMS) such as Deviations, CAPAs, Change Controls, and Effectiveness Checks
• Accountable for QA-CQV regarding validation documentation review and approval, protocol deviation review/approval, and regulatory expectations on qualification and validation
• Accountable to establish, track and present Quality Metrics to support Quality Management Review.
• Accountable to report metrics out to corporate
• Responsible for the Site Risk Management process
• Utilize technical and compliance knowledge to analyze risk, troubleshoot complex issues, approve protocols, and/or investigate complex deviations.
• Create/Review/Approve procedures and/or reports as needed
• Review and approve OOS and/or excursion investigations in QC.
• QA floor support (Quality Oversight, logbook review, solve issues real time with operations personnel, etc.).
• Develop direct reports (developmental plans, cross-training, etc.)
• Provide support and participate in internal and external, and other regulatory agency inspections (FDA, EMU, etc.).
• Encourage and actively drive the vision where employees and managers are all engaged in a culture focused on managing and developing talent.
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.
MINIMUM 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 Systems.
• Previous people leadership experience 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 prepare reports for internal metrics and technical content
• Must be able to critically evaluate data summaries and conclusions.
• Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.
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.