Sr Manager, QC Compliance & Data Management

Location
Baltimore (Bayview), MD, US
Posted
Oct 14, 2020
Ref
675417400
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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

Responsible for managing the QC Compliance and Data Review group to ensure the testing and documentation are accomplished efficiently and in compliance with cGMP rules and regulation. The manager will serve in supporting compliance of all QC areas including deviations, CAPA's, OOS investigations, data integrity, and training.

II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Provide oversight of Quality Control operations including Deviation, CAPA, Document Control, Product Testing, Batch Record Review, Product Release, and Change Control.
• Establish and maintain a document control system for Quality System documents and associated documents used and generated on the site that are compliant with regulations to support business operations.
• Provide oversight for training personnel and management of training processes and content.
• Represent Quality Control and Emergent during FDA regulatory agency and ISO inspections.
• Represent Quality Control and Emergent for customer relation activities.
• Provide management coordination of various compliance documentation such as:
o deviations, CAPAs, audits, change controls, validation & technical study protocols and other cGXP compliant documentation.
• Provide management coordination of:
o Testing (routine and validation) conducted by Contract Laboratories
• Perform Management Review and Approval function for:
o Product release specifications, raw data review associated with finished product, and stability sample test results, validation, technical studies and notebook studies, developmental results, method validation protocols (IQ, OQ, PQ) and SOPs
• Ensure compliance with the cGMPs regulations and current procedures
• Conduct lab audits and participate implementing lab improvement to ensure GMP compliance.
• Communicate metrics, trends, and data summaries to senior management as part of Management Review, using a variety of media: intranet, reports, and presentations
• Maintain metrics within predetermined limits.
• Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements.
• Manage employees with various experience levels with capability to develop new leaders, individual contributors, and technical experts.
• Interact with contract, corporate, ISO and governmental agency auditors.
• Conduct personnel interviews, performance reviews, develop and administer development plans, follow-up on personnel issues, and provide feedback to group.
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
• B.S. degree in microbiology, Biochemistry, or closely related scientific discipline with at least 10 years of relevant experience or M.S. degree with a minimum of 5-8 years of relevant experience.
• At least 5 years prior supervisory experience in a GMP Quality Assurances or Quality Control laboratory required.
• Must have sound knowledge of the functions and expectations of a QC Laboratory in parenteral drug manufacturing and proficiency in Good Manufacturing Practices in an FDA regulated manufacturing facility. Preferably possess skills and general knowledge of QC methods such: as ELISA, qPCR, Viral and Cell-based assays, SDS-PAGE, Western Blot, UV, sub-visible particle analysis, Bioassay, microbiology assays and environmental monitoring .
• Ideal candidate will have laboratory skills that include compendial testing such as appearance and fill volume, container closure integrity testing, and simple analytical instrumentation.
• Previous LIMS experience is desired.
• Experience in assay method transfer, product release, and raw material testing and release.
• Advanced knowledge of cGMPs, safety and data integrity.
• Experience in laboratory control including sample accessioning and product testing.
• Experience in oversight of QC laboratory investigations including root cause analysis, OOS, and invalid assay investigation.
• Knowledge of Good Manufacturing Practices and Good Laboratory Practices.
• Must be highly organized, detail oriented and able to manage multiple projects.
• Solid communication and presentation skills required.
• Must understand cGMPs, CFR, USP, and Aseptic Processing Guidelines
• Must have prior experience with regulatory (FDA/USDA) inspections

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

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.