Quality Operations Manager
Clinigen
Manager, Lab Data Management
Thermo Fisher Scientific
full-time
Posted on:
Location: Wisconsin • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Fully remote role supporting the GMP Lab in Middleton, WI; prepares and reviews data management documents to meet or exceed quality expectations.
- Interacts with the laboratory to determine the format and design of complex data management documents for potential submission to regulatory authorities.
- Uses data entries and information to develop report text and ensures compliance with required formats.
- Serves as a departmental resource for training, mentoring, and development of process improvements.
- Supervises daily work activities of the data management staff to ensure efficient and effective operations and provides short- and long-term resource planning.
- Evaluates timeliness and quality of deliverables and provides updates to senior management, including tracking of key performance indicators (KPIs).
- Ensures staff compliance with documented procedures and prepares/assists in preparation of data management documents such as methods, protocols, reports, summaries, and SOPs.
- Compiles laboratory data into specified formats and ensures hardcopy and electronic reports are consistent and comply with required formats; edits and performs quality control review of reports and reviews data tables and listings for accuracy.
- Organizes processes for data management documentation, represents the data management team in initiatives, and collaborates with other department heads on process improvements.
- Keeps updated on guidelines and requirements of regulatory agencies to ensure that information is available for staff.
- Provides assistance and resource information to departmental and laboratory staff; trains and mentors other data management and laboratory staff and assesses competency, issuing formal evaluations.
Requirements
- Must be legally authorized to work in the United States without sponsorship.
- Must be able to pass a comprehensive background check, which includes a drug screening.
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience (5+ years) in a related field.
- Understanding of laboratory scientific data and their systems such as laboratory information management systems (LIMS), electronic laboratory notebooks (ELN), and scientific data management systems (SDMS).
- 1+ year of leadership responsibility.
- In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient.
- Good working knowledge of scientific terminology, medical, pharmaceutical, and research concepts.
- Working knowledge of data management procedures and regulatory requirements.
- Strong time management and project management skills.
- Excellent written and oral communication skills.
- Proficient with Microsoft Office.
- Strong attention to detail.
- Strong editorial/proofreading skills.
- Proven problem-solving and troubleshooting abilities.
- Demonstrated leadership abilities; ability to motivate and train staff individually and in a team environment.
- Clear understanding of broader GMP labs testing process and challenges of lab data used in GMP.
- Good organizational and interpersonal skills; ability to adapt to changing priorities and manage multiple assignments with conflicting deadlines.
- Strong computer skills and knowledge of databases and how to effectively extract and interpret data.
- Ability to maintain a high degree of confidentiality with GMP data and client’s proprietary data.
- Able to work upright and stationary and/or standing for typical working hours; repetitive hand movement of both hands; moderate mobility required.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Able to communicate, receive, and understand information and ideas with diverse groups of people.
