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Sr Manager, Analytical Quality

Employer
Emergent BioSolutions
Location
San Diego, CA
Start date
Sep 25, 2022

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Discipline
Information Technology, Business/Data Analytics, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach

Job Details

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.

Reporting to the Director Development Quality, the Sr. Manager, Analytical Quality, is a quality assurance professional responsible for oversight of Analytical Method Development and GxP Lab Operations including, but not limited to, qualification/validation of analytical methods and method transfers, GxP data review, Product specifications, CoA approvals, stability study oversight.

This position frequently interacts with area team leads, supervisors and other cross functional peers.

 

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

•    Accountable for clinical and development product testing in Analytical Development, Quality Control, Contract Testing Labs, and GxP labs. 
•    Review and approve, as necessary, Standard Operating Procedures, analytical test methods, Product specifications, Stability protocols and reports, technical transfer packages and other documentation used in the developmental analytical testing of product.
•    Audit laboratory and other documentation associated with analytical testing of product
•    Review and approve Quality Events such as Deviations, Investigations, CAPAs,  Change Control; and other GxP documentation
•    Review and Approve Certificate of Analyses for the release of clinical materials tested across multiple sites.
•    Review and approve stability study data and shelf-life extensions.
•    Review of technical transfer packages. 
•    Oversight of all GxP laboratory data review and assay qualifications for testing of clinical patient samples.
•    Provide input and develop content of GxP training materials for GMP and GCLP functional groups 
•    Interact with stakeholders to provide guidance necessary to maintain and improve compliance within the GxP Laboratories.  
•    Lead the team through hiring, performance reviews, training and coaching to self-sufficiency.
•    Act as subject matter expert of analytical data review, identify opportunities for improvement, and support implementation, as necessary.
•    Manage the Quality assurance team in achieving improved customer satisfaction/loyalty and business excellence. Advocate for the customer and communicate to senior management 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.
•    Review of analytical method  transfer packages. 
•    Quality reviewer of CMC sections for regulatory submissions in strong partnership with authors on development teams Lead initiatives for process harmonization and Quality Standards implementation at San Diego site and serve as liaison across Emergent global network driving initiatives for quality events. 
•    Coordinate and support the development and execution of change control plans to ensure compliant implementation of product and/or process changes
•    Oversight of assay qualifications for testing of clinical patient samples
•    Review and approve Certificates of Analysis for the release of clinical materials tested across multiple sites

Quality System Support

•    Author, review, execute and approve tasks for document revisions, non-conformances, CAPAs, deviations, change controls and other GMP documentation.
•    Perform gap assessment as needed to support quality harmonization and improvement initiatives


Management/Competencies 

•    Demonstrate initiative and accountability in a fast-paced environment with minimal supervision
•    Strong hands-on knowledge and ability to identify and/or independently resolve moderately complex quality issues with other functions in a proactive, tactful, flexible and constructive manner.


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 of Science in Biology, Chemistry, Physical Sciences, or related degree.
•    Minimum 10 years of QC and/or QA experience in cGMP environment with Management Experience overseeing direct reports
•    Knowledge of 21 CFR 210, 211, 600 requirements
•    Knowledge of analytical method qualification and validation 
•    Knowledge of biological assay qualification and validation is a plus.
•    Solid understanding of US and European regulations including application in the day-to-day environment.  
•    Solid problem solving and critical thinking skills
•    Ability to work well in a fast-paced, team-oriented environment
•    Excellent organizational ability – can easily multi-task and shift priorities as needed
•    Works independently with moderate supervision
•    Must have good written and verbal communication skills.  The ability to tailor communications to all levels in the organization and prepare appropriate updates to functional groups.  
•    Experience in vaccines development and manufacturing is a plus.  
•    Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required

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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.

Company

Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.

Stock Symbol: EBS

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Company info
Website
Phone
240-631-3200
Location
400 Professional Drive
Suite 400
Gaithersburg
Maryland
20879
United States

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