Sr Dir, Inspection Readiness & Compliance

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 Sr. Director, Global Quality Inspection Readiness and Compliance (MD) is responsible for overall governance of ensuring network/site(s) preparedness for regulatory agency audits and inspections across all Emergent sites in the Maryland area.  These strategic activities include the development, enhancement, and deployment of quality standards/procedures/work instructions, electronic and paper-based tools, and ways to monitor, measure, and communicate effectiveness. This role will have direct oversight of the site compliance leads for each under his/her responsibility and will ensure that the site maintains an efficient and effective self-inspection program.

The Sr Director, Global Quality Inspection Readiness and Compliance (MD) also has the responsibility of maintaining along with the Sr Director, Global Quality Inspection Readiness and Compliance (ROW) a 2–4-year strategic outlook based on changes to regulations and guidance documents. This position requires close cross-functional teamwork, external networking, ability to understand and communicate risk, and a desire to coach and develop others. 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.

• Lead inspection readiness initiative and collaborate with Emergent Quality Management System, Compliance, and Site teams to ensure alignment across the organization.
• Enhance, maintain, and update the Emergent inspection readiness “game-plan”
• Establish, lead and support routine gap analysis of Emergent processes and lead the efforts in preparing a strategy for correction.
• Actively assist with regulatory authority inspections, including the drafting of responses.
• Create and prepare monthly, quarterly, and annual status updates with regards to inspection readiness for each site. 
• Global Process Owner for Inspections, enhancing how Emergent preps, runs, and executes hosting audits and inspections.
• Partner with site QA Heads to establish roles and responsibilities for Audit/ Inspection Readiness, ensuring consistency across all sites. 
• Provide Corporate support regarding the development, deployment and inspection readiness for Emergent operations including maintaining effective data management systems to maximize automation of data processing and analysis in support of Inspection activities. 
• Facilitate strategic planning for companywide GXP Inspection Readiness (site specific Inspection Plans, Roles and Responsibilities Schedule, Inspection database set-up, Inspection Logistics and Training), and reporting/escalation of opportunities for process performance improvements or risk mitigation activities. 
• Ensure timely and thorough communications to Executive and Site Management and personnel regarding Inspection Readiness, Inspection updates and compliance actions. 
• Partner with Site QA Heads and Regulatory Affairs to develop mitigation and response plans to GXP Inspection observations, including assessment of observations across all sites and development of global corrective action plans.
• Participate in Quality System Harmonization efforts that meet / surpass industry best practices and regulatory expectations.
• Partner with site QA Heads to facilitate continual improvement programs utilizing Six Sigma and Lean concepts.
• Ensure fiscal responsibility through effective operational and capital budget planning and cost center management to plan.
• Assure effective communication tools, including structured meetings and publicly available (e.g., intranet) documents, are established and maintained. 
• Develop effective metrics and monitoring programs to assure constant vigilance with respect to Inspection, Audit and Training Management.
• Develop a program to keep management of all sites abreast of GxP Industry and Compliance trends. 
• Conduct education programs regarding Industry and Compliance trends. 
• Participate in the site Quality Management Reviews and global Management Review to ensure active monitoring of compliance of the site.
• Prepare the annual Site Compliance report for each site under his/her responsibility.
• Oversee the efficiency and effectiveness of the site self-inspection program for each site under his/her responsibility.
• Travel as needed to Emergent sites.

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.
• Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance.
• Ability to train and mentor site subject matter experts to develop their knowledge and understanding of quality compliance.
• Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product commercial operations.

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.