The Quality Control Manager is a senior member of the Quality Control (QC) laboratory, responsible for managing Quality Control analysts, leading and executing analytical validation including generating/reviewing external protocols, computer system validation, supporting company’s Digital Quality Management System (QMS) and Electronic Laboratory Notebook (ELN), compliance to 21 CFR Part 11 compliant of all QC laboratory equipment, and function as laboratory system administrator to all electronic data systems. This role oversees quality control data and assay integrity that includes out of specifications, deviations, and other aberrant incidents, raw material testing, reagent controls, stability release, optimizing analytical assays, actively contributing to the development of new validation protocols and procedures, and review of all internal and external quality documents prior to submitting to Quality Assurance. This position will require regular, collaborative interactions with co-workers across functional groups and departments. Strong interpersonal skills, outstanding verbal and written communications skills are essential.

Essential Duties and Responsibilities:

Responsibilities include but are not limited to:

- Quality Control Manager will have overall responsibility to manage and control all QC activities including managing staff in accordance with identified SAB Quality Systems and Standards as well as all relevant regulatory and legislative regulations across the lifecycle of the Site products related with the biological controls. Manage QC activities and meet deliverable timeline expectations.

- Lead and execute validation of QC analytical assays, including ELISA, PCR, HPLC, aseptic technique, and physical property characterization using internal resources or CSPs.

- Lead and execute the integration, training, and validation of a quality control ELN, computer system validation and instrument specific software validation compliance to 21CFR Part 11 as well as function as laboratory system administrator.

- Support the selection and integration of a comprehensive digital quality management system (QMS) and manage the integration with existing software modules like SAP, hardware systems, and regulatory compliance.

- Manage schedule and workflow with adequate communication to staff and timelines, OOS/Deviation investigations with CAPA resolution, raw material program, reagent/controls qualification program, environmental monitoring program, stability program, and microbial testing including performance review.

- Writing documents and reports to support regulatory submissions independently working under GLP and/or cGMP guidelines.

- Review and maintain accurate QC records and inventories related to computer systems (internal or from CSPs), and validated data spreadsheets.

- Mentor junior staff and provide guidance on assay optimization and compliance to data integrity.

- Actively contribute to the development of new SOPs, data records, and development reports.

- Independently maintain calibration program and analyst cross functional training program in the QC department.

- Perform other duties as assigned.

Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education, Experience and Certifications:

- Bachelor’s degree in relevant field such as Chemistry, Biology, or Computer Science is required. Master’s degree preferred.

- Experience with Computer System Validation and familiarity with regulatory guidelines (21 CFR part 11, in particular) is a major plus.

- 3 years of combination of experience and education preferred.

Core Competencies, Knowledge, and Skill Requirements:

- Proven track record and experience with biopharmaceutical digital QMS integration and management.

- Prior experience with biopharmaceutical cGMP manufacturing, and/or regulatory compliance.

- Team player with high emotional intelligence who is organized, diligent, and thoughtful with outstanding leadership, communication, and project management skills.

- Skillful use of interpersonal skills and influence to drive results and meet project objectives without formal authority over internal and external team members.

- Self-directed and proactive with ability to function independently in certain situations, exercise good judgment and respond quickly and effectively to changing environments.

- Adaptable, responsive to challenges, and able to generate options for moving forward.

- Effective distillation and communication of key messages from complex discussions, translating strategy into action.

- Adept at time management and navigating competing and changing priorities in a fast-paced, rapid-growth environment.

- Technical and/or project management experience in development of a biologic product

- Demonstrated experience building and managing relationships, teams, budgets, and timelines.

- Conflict resolution, critical thinking, and real-time problem-solving skills.

- Working knowledge of project management tools; strong computer skills and experience with software such as MS Project, Excel, SharePoint.

- General knowledge and understanding of GxP, US and EU regulations preferred.

- Understanding of drug research & development phases with emphasis on preclinical and early-stage clinical development

Language Skills:
Individual should possess strong communication skills and proficiency in Microsoft Office software (Word, Excel, PowerPoint and Outlook) as well as the ability to effectively present information in one-on-one and small groups.

Mathematical Skills:
Basic mathematical skills to consist of addition, subtraction, multiplication and division. Able to calculate concentrations, dilutions, molarity and basic statistical analysis.

Physical Demands:
While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee must be able to move up to 50 pounds. Specific vision abilities required by this individual include close vision, peripheral vision, and the ability to adjust focus. The employee will view a computer monitor for long periods of time.

Physical Requirements/Working Conditions: Job requires good physical mobility. Ability to move over 50 pounds by mechanical means. Be able to sit for extended periods of time.

Working Environment:Duties will be performed in normal laboratory and BSL2 laboratory.

ADA:
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• Sioux Falls, SD: Relocate before starting work (Required)

Work Location: In person