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Assistant General Counsel - Quality and Manufacturing Compliance-Remote

Employer
Emergent BioSolutions
Location
Gaithersburg, MD
Start date
Jul 27, 2022

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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.

I.    JOB SUMMARY 

Assistant General Counsel - Quality and Manufacturing Compliance provides legal support to quality, manufacturing, and supply chain for 9 manufacturing sites. Specific responsibilities include legal advice related to current Good Manufacturing Practices (cGMP), regulatory compliance, supply chain, and quality management.

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

•    Provide strategic legal advice related to quality, manufacturing & supply chain including: regulatory and compliance matters including cGMP compliance,  , third-party vendor relationships, , manufacturing operations, responses to regulatory inspection findings, SOW review, internal program reviews, quality improvement plans, audits, investigations, resolution of internal and customer issues, and preparation and training for audits and inspections. Anticipate and provide legal analysis to mitigate risks associated with program process and product and supply issues.  Review and provide legal input on control documents related to data integrity, governance, and other controls.

•    Provide legal advice ensuring compliance with all FDA and related laws and regulations.

•    Provide strategic legal advice and proactive solutions to quality and manufacturing teams. 

•    Represent Legal on various cross-functional committees and teams.

•    Collaborate closely with Quality, Regulatory, Commercial, Compliance, and Medical on a wide array of quality and compliance issues.

•    Provide education and training of Quality and cross functional stakeholders on adherence to FDA guideline, laws and regulations.

•    Actively participate in department initiatives, identifying opportunities to enhance effectiveness of Legal department operations

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

•    Law Degree from an ABA accredited school and licensed and in good standing in at least one U.S. State

•    A minimum of 10-12 years of experience practicing law with at least 7 years working at FDA or in a law firm and/or pharmaceutical or biotechnology legal department supporting quality and manufacturing.

•    Strong ability to grasp legal issues quickly, exhibit strong analytical problem solving and decision-making skills, exercise sound judgment, and provide practical and constructive legal advice in a time-sensitive, dynamic, and fast-paced complex environment.

•    Strong negotiation and communication skills (both oral and written). Ability to communicate legal issues in a clear and understandable manner. Builds relationships across functions and sites and inspires trust and confidence through effective communication and interpersonal skills.  Experience working in a matrix environment is desired.

•    Ability to work independently and take initiative to drive forward priorities, complete tasks and appropriately manage risks.

•    Strong work ethic and ability to manage large workload, including effectively engaging and managing external counsel when appropriate, focus on critical priorities, and otherwise effectively meet client needs directly and with members of the Legal team. 

 

Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment,  subject to legally required exemptions.

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