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
The Manager, QA Document Control will foster psychologically safe and inclusive space to encourage a strong collaborative work environment across the Emergent enterprise. Reporting to global quality leadership, this manager is responsible for maintaining a modern and compliant document management program, and effectively managing staff to ensure efficient execution of such program to support daily business needs. This individual is responsible for recruiting and retaining and developing talent to appropriately staff the function, and represents the function in audits and inspections.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Lifecycle Maintenance of Document Control Program - Participating in global governance community for Global Quality Training Program, bringing subject matter expertise to represent site or process specific issues and solutions to drive continuous improvement to Document Control Program effectiveness and efficiencies. Soliciting input from stakeholders related to process improvement.
- Supervises daily operations he of the Document Control staff to ensure effective and efficient execution of critical processes.
- Manages the development needs of Document Control staff to support evolving quality systems and modern solutions.
- Collects, monitors, and reports functional metrics to effectively manage quality risks and functional performance.
- Aids in the development and maintenance of document templates that are modern, streamlined and fit-for-use.
- Maintains a working knowledge of EDMS system (Veeva) to facilitate end user training and provide exceptional service to support end user experience.
- Manages the electronic document management system and lead process improvement by developing and implementing plans to evolve internal systems for greater efficiency and quality.
- Manages the document management system to issue, retrieve, and archive controlled documents as needed by the site.
- Ensures Emergent documentation retention requirements are applied to GXP documents.
- Authors and executes tasks for document revisions, non-conformances, CAPAs, and change controls related to Document Control quality system performance.
- Provides and coordinates support to stakeholders with a customer service midnset
- Actively engages within the global community of practice to maintain alignment and consistency in the execution of document management across EBSI.
- Provides support during internal/external audits and regulatory inspections.
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
- BS degree, preferably in a life science or library science related discipline, accompanied by 10 years of job related experience or combination of education and work experience.
- Minimum of 5 years in an FDA regulated industry or Quality Assurance.
- Minimum of 3 years people leadership experience
- Must possess strong computer skills in the Microsoft Office product line.
- Working knowledge of SAP is preferred.
- Working knowledge of Veeva Vault preferred.
- Must be able to effectively communicate (orally and written) with all levels of personnel.
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.
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.