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Sr Dir Sterility Assurance & Contamination

Employer
Emergent BioSolutions
Location
Gaithersburg, MD
Start date
Nov 20, 2021

View more

Discipline
Quality, Quality Assurance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital

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.

The Senior Director of Quality – Sterility Assurance and Contamination Control is responsible for overseeing and developing the Sterility Assurance and Contamination Control Program across all Emergent sites, e.g., Baltimore Bayview, Baltimore Camden, Canton, Gaithersburg, Hattiesburg, Lansing, and Winnipeg.

 

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

•    Sponsor for all global quality standards related to sterility assurance and contamination control.
•    Sponsor for the Micro Center of Excellence.
•    Responsible for the promotion of contemporaneous Sterility Assurance and Contamination Control across the Emergent Network.
•    Develops and monitors appropriate metrics to track quality and process improvement around sterility assurance and contamination control.
•    Ensure that internal processes and metrics are aligned to create visibility and monitoring of the state of control of sterility assurance and contamination control.  
•    Is a key member of the Global Quality Leadership Team.
•    Responsible for helping to lead teams across the network in an integrated way that supports the delivery of corporate quality goals related to sterility assurance and contamination control.
•    Provides leadership and strategic direction to all sites with regards to sterility assurance and contamination control global initiatives.
•    Ensures the proper interface of the quality function to product development manufacturing, engineering/maintenance, and other areas as required.
•    Builds strong relationships with internal and external customers-to build, enhance and ensure quality awareness.
•    Works with the sites to provide development and training to site resources to prepare them to effectively support the deployment and maintenance of appropriate sterility assurance and contamination control practices.
•    Support sites during critical investigations into sterility assurance / contamination controls to arrive at root cause and establish effective CAPA.
•    Perform gap assessment of site operations (current and planned) to identify and remediate potential gaps related to sterility assurance or contamination controls.
•    Support global auditing team for site and/or supplier audits with regards to technical expertise in sterility assurance and contamination control.

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
•    BS degree in Science; Advanced Degree (s) preferred
•    Seasoned Quality Assurance professional with a minimum of 15 years of experience in biopharmaceutical/vaccine companies
•    Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product development/clinical manufacturing and commercial operations.
•    Should have an excellent understanding of Quality requirements in both the US and EU.  
•    Proven expertise in the design and implementation of sterility assurance and contamination control practices in a world-class medical device/pharmaceutical/vaccine manufacturing organization 
•    Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance.
•    Must have technical knowledge of manufacturing, process design and improvement, sterility assurance and contamination control.
•    Must have a track record of success and a broad understanding of contemporary quality practices to the position.
•    Ability to train and mentor site subject matter experts to develop their knowledge and understanding of sterility assurance and contamination control.
•    Excellent verbal & written communication skills.
 

 

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.

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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