Manager, QC Data Services

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.

I. JOB SUMMARY

The Data Services Manager will provide oversight of Data Services across the QC Laboratory Services group. The Data Services group (DST) works with systems owners and business process owners (BPO) to provide data custodianship for Data Integrity (DI) through the design and operational lifecycle of software and firmware-based instrument system applications within QC. The DST provides business unit, administrator-level support for the systems as required to accomplish data custodianship. The Data Services Manager (DSM) establishes and manages the processes required to meet DI expectations for data custodianship and regulatory requirements. Responsibilities of the team include, but are not limited to, activities relating to system change control, DI assessments, IOPQ, CSV, training, administrator duties, deviations, and periodic review of audit trails and configuration specifications for systems. The scope of activities applies to new and existing equipment and software. Coordinates the selection, procurement and commissioning of new systems and upgrades with QC senior management. This position will not perform any GxP testing. Typical hours are 8:00am - 4:30pm, Monday through Friday. Hours may vary to meet business and training needs.

II. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.• Establishes and maintains processes for data custodianship throughout the design and operational lifecycle for local QC software and firmware-based equipment, excluding enterprise solutions such as LIMS. Business unit administrator of local software and firmware applications, excludes site-level administrator responsibilities for enterprise solutions. • Manages or owns all CCRs for software and firmware-based equipment with Data Integrity (DI) impact to electronic data; includes new software and software/firmware updates. • Establish and maintain a risk/criticality-based program for periodic review of audit trails for project level data. • Establish and maintain a process for user account management for software and firmware-based applications. • Assess the compliance status of software and equipment configuration and associated procedures for new and existing software. Establish new processes where needed. Assist all CSV related periodic reviews as QC SME and owner of related tasks.• Approval of DI Assessments and manages/owner of all related CAPAs and/or CCRs.• Writes and approves DI related deviations.• SME for QC support of Validation activities, i.e., drafting user requirements, configuration specifications, data flow diagrams, PQ protocols, periodic review, and execution of protocols.• Organizing meetings and/or training related to projects.• SME or owner for Risk Assessments, observation CAPAs, etc. related to Data Integrity and new technology introduction. Role may vary as author, reviewer/approver, participator, or owner depending on task.• SME in equipment selection, procuring and commissioning; including authoring CAPEXes, change controls, SOPs, etc. as needed for Analytical/Micro; focusing on equipment with DI impact.• SME for global/enterprise solutions, e.g., LIMS and Empower3. Includes attending meetings and training as it pertains to the laboratory and completing project- or site-change control-oriented tasks if there is DI impact.• Authors and/or reviews/approves technical documents as SME such as IOPQ documents and technical protocol/reports related to commissioning of equipment/software.• Conduct training sessions for new protocol and standard operating procedures, mentoring QC personnel to develop laboratory core competencies for operations and data integrity.• Assist with client or regulatory tours of the laboratories with respect to Data Integrity.• Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.• Support department compliance, data integrity, and capital spendings goals.• Participation in biomedical monitoring required.• Does not directly create, generate, acquire, etc. GxP data and is accountable for maintaining clear separation of role in all activities with respect to data integrity and administrative-level access on equipment.

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

Education and Experience: A minimum of a B.S. in Chemistry, Biochemistry or related scientific discipline with a minimum of 6+ years' experience. Experience must include 2+ years in a Quality Control laboratory environment directly executing change controls for commissioning of new equipment and software.

Must have sound scientific background in analytical chemistry and typical applications. Must have experience in and demonstrate broad knowledge in validation and change control, including commissioning activities for laboratory equipment and software. Must have sound knowledge of IOPQ process and understand principals of validation. Must have sounds knowledge of current good data integrity practices and industry related expectations. Must have experience in quality control change management.

Demonstrates knowledge and application of typical regulatory guidance such as cGMPs/GLPs, ICH, FDA, EMA, and CMC documents. Demonstrates knowledge and leadership in data integrity principles. Demonstrates knowledge of quality control regulatory requirements. Demonstrates leadership and mentorship across all quality control processes. Demonstrates proven leadership in department goals and independent management of projects. Expected to be familiar with CFR, USP, and EU regulatory requirements. Demonstrates solid communication and presentation skills. Demonstrates cross functional understanding and result-driven abilities.

Must be highly organized, detail oriented, and able to manage multiple projects and work with cross-discipline personnel. Must be capable of independent management of long-term projects. Expected to make independent decisions for near-term goals. Strong problem solving and root cause analysis skills. Strong analytical and strategic thinking skills are expected.

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

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.