Sr. Director, Technical CoE

Location: 

Gaithersburg, MD, US, 20879


 

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

The Senior Director of Quality – Technical Center of Excellence (CoE) will play a central role in developing, implementing, maintaining, and improving strategic and technical quality. The role will provide leadership and collaborate with required functional areas to ensure global technical quality support in the areas of engineering, sterility assurance and contamination control and QC to ensure product quality local and international applicable regulatory requirements. The Senior Director is expected to build and maintain cross-functional relationships with key functional areas including but not limited to: Manufacturing, Quality Control, Regulatory Affairs, Supply Chain, Business Development, and Clinical Operations.

Role will report directly to the Vice President, Enterprise GxP Compliance & Systems.

 

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

  • Serves as the strategic leader to oversee and manage all technical quality assurance activities.
  • Provide leadership, direction, and mentorship across all levels of the organization to assure Technical CoE strategies are known and implemented.
  • Support continuous improvement efforts, while maintaining highest level of quality.
  • Hire, develop, and retain quality personnel to create a high-performing credible team.
  • Oversees and / or collaborates on sponsorship for all global quality standards related to Technical CoEl.
  • Oversees and / or collaborates on sponsorship for all Technical CoE Communities of Practice.
  • Responsible for the promotion of contemporaneous Technical CoE areas of activity across the Emergent Network.
  • Develops and monitors appropriate metrics to track quality and process improvement around Technical CoE areas of activity.
  • Ensure that internal processes and metrics are aligned to create visibility and monitoring of the state of control of Technical CoE areas of activity.  
  • Responsible for helping to lead teams across the network in an integrated way that supports the delivery of corporate quality goals related Technical CoE areas of activity.
  • Provides leadership and strategic direction to all sites with regards to Technical CoE 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 Technical CoE practices.
  • Support sites during critical investigations into Technical CoE areas of activity to arrive at root cause and establish effective CAPA.
  • Support global auditing team for site and/or supplier audits with regards to technical expertise in Technical CoE areas of activity.

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

  • Degree level in chemistry, Biochemistry, Biology, Microbiology or related science discipline, Advanced degree an advantage.
  • Minimum 15 years of QA or Compliance experience supporting GMP, GLP, and/or GCP operations in drug, biologic and medical device industries under FDA regulations, ISO 13485 and ICH Guidelines.
  • People management experience (direct/matrix).
  • Excellent leadership, interpersonal, communication, negotiation, and problem-solving skills.
  • Thorough understanding of relevant principles and source reference documents, including Biochemistry, manufacturing science, Lean/Six Sigma principles, Quality Control, Quality Assurance, Quality System principles, U.S. FDA and international regulatory regulations and guidance’s. 
  • Excellent organizational awareness (e.g., Research & Development, Commercial Manufacturing, interrelationship of departments, business priorities), including significant experience working cross-functionally and in global, cross- cultural teams.
  • Experience developing and executing large-scale global organizational change, including change management strategy and planning.
  • Proven ability to understand complex processes/problems and facilitate/coach teams to optimal solutions. 
  • Ability to design and implement global business processes/policies with a critical thinking approach and enterprise mindset. 
  • Proven experience managing/influencing stakeholders across a broad spectrum of GxP topics.
  • The ideal candidate will have excellent written and oral communication abilities. 
  • Must be able to present complex theoretical concepts and empirical performance data effectively in both oral and written formats, for audiences ranging from senior executives through entry level employees. 
  • Must exhibit strong leadership skills, both with subordinates and peers, with particular emphasis on relationship development and implementation of company culture improvement initiatives. 
  • Extensive experience with industry-standard software applications (Microsoft Word, Excel, PowerPoint). 
  • Ability to effectively maintain a culture of continuous improvement is essential.
  • Operational Excellence/Lean Six Sigma experience a plus.
  • Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product commercial operations.
  • Ability to train and mentor site subject matter experts to develop their knowledge and understanding of Technical CoE.

 

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Lead with Integrity
    • We gain trust and confidence through ethics, quality, and compliance excellence
  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Washington DC