Sr Manager, Quality Assurance Systems

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 Senior Manager Quality Assurance/Systems for the San Diego location will oversee the development, design, and maintenance of the site Quality Assurance Systems with the goal of maximizing efficiency, effectiveness, and compliance with GxP regulations while working with all teams in a matrix environment and employing lean tools. 

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Primary Responsibilities
Periodically assess the effectiveness of the Quality Management Systems via Quality Management Reviews and other established monitoring processes and metrics.  Manage and oversee the QMS transformation activity for the San Diego site and ensure site deliverables are met.
Specific Responsibilities
This role serves as a QA lead for all Quality Systems, Document Control, Training, Data Integrity and related matters as necessary. 
Lead the team through hiring, performance reviews, training and coaching and self-sufficiency.
•    Manage contract test labs to ensure appropriate testing and documentation, and turnaround times are aligned with project timelines
•    Collaborate with Project Management to coordinate Quality activities pertaining to project timelines.
•    Review of CMC submissions as it relates to analytical methods and QC activities
•    Participate in internal and external audits and regulatory inspections. Coordinate and plan inspection preparation and readiness (announced or unannounced) with documentation review, accomplishment of audit deliverables and logistic of hosting and audit/inspection. Coordinate the response following audit/inspection including drafting responses, drafting periodic updates (as required) and ensuring adequate follow-up on suggestions for improvement (e.g., FDA EIR notes, recommendations, etc.) withing Emergent Quality Systems (as appropriate)
•    Notify Senior Management of potential quality or regulatory issues that may affect delays to project timelines with proposed solutions and deadlines. 
•    Lead the San Diego Quality System team in achieving improved customer satisfaction/loyalty and business excellence. Advocate for the customer and influence senior management on critical customer issues. Communicate Quality strategies, key quality concepts and regulatory requirements effectively to all levels of the organization. Build positive customer relationships through presentation, listening and consultative skills.
•    Oversight of the Quality Systems including but not limited to Supplier Initiated Changes, CAPA, Document Control, Training, Change Control, and Product Complaints, Inspection Readiness, Quality Management Review
•    Promptly notify Quality management of potential issues or problems. 
•    Oversee the Training department activities to include but not limited to on time completion of training assignments, appropriate routing of documents in Veeva, SAP and other Quality Systems. 
•    Lead and oversee all Data Integrity initiatives and assessments to point of development of sustainable processes. 
•    Manage and oversee activities related to SCARs and Supplier Change Impact Notices (SCIN).
•    Lead and oversee products and programs as necessary by working cooperatively with all teams in a matrix environment.
•    Oversight of Quality Systems to ensure alignment with Global Compliance policies, procedures and standards. Provide oversight to Key Performance Indicators (KPI) and any other metrics. 
•    Foster a culture of innovation, continuous improvement and personal accountability in interactions with direct reports and others by utilizing six sigma and lean tools. 
•    Share best practices within the team and across functional teams. 
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 Life Sciences disciplines and 10years of experience in cGMP lab environment or Master's degree in Life Sciences disciplines and/or 8 years of experience in cGMP lab environment.
•    Experience managing scientific projects and personnel a plus.
•    Knowledge of cGMP, ICH, USP and global compendia regulations and guidance documents.
•    Experience managing in a GMP environment.
•    General knowledge of Six Sigma and lean tools.
•    First hand or intimate knowledge of biochemical, biological and immunological assay development is highly desirable.

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.
 

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.