The Senior Manager, Quality effectively plans, organizes, staffs, leads, and controls several sustained testing product lines or technological transfer teams within Quality. Will autonomously supervise the testing, assessment, technical transfer, and advanced troubleshooting of protein-based immunoassays. The incumbent must be able to lead, define priorities, and direct the work of supervisors, including determining the scope of work assignments and work schedules/deadlines. The incumbent is anticipated to be able to handle several projects autonomously while also providing oversight and assistance to team members as needed. This job is also in charge of establishing, performing, and maintaining compliance with quality requirements for document and record control.
DUTIES AND RESPONSIBILITIES:
* Shorten cycle times to increase productivity for scheduling, testing, data evaluation, and product(s) disposal for numerous product lines and/or technical transfer of new products.
- Evaluating problems with maintaining goods that have been released, communicating, and creating plans for putting fixes into action.
- Implement and maintain systems for tracking the effectiveness of consumables goods that have been made available so that you can proactively spot possible problems and possibilities for process or product enhancements.
- Take the lead on projects to improve processes and best practices.
- When necessary, coordinate cross-functional activities with PC, PD, Analytics, Operations, and other departments to address/prevent problems with products that have been published
- Understand and follow laboratory safety precautions and ensure compliance with company safety policies
- Create, update, and put into practice SOPs
- Where applicable, accountable for the work of others under their supervision
- Assist, guide, coach, and record performance assessments
- May be in charge of development and training
- Specific responsibilities may change based on departmental requirements.
- Present to senior management teams or cross-functional teams.
EXPERIENCE AND QUALIFICATIONS:
- A bachelor's degree in biology, chemistry, biochemistry, cellular/molecular biology, life sciences, protein sciences, or a closely related field is necessary.
- A master's degree would be ideal.
- A degree may be replaced by further experience.
- A full understanding of Quality Control needs and 8+ years of expertise in reagent, product, or assay development in an industrial setting are essential.
- You must have 5+ years of managerial experience.
- An environment subject to ISO/GMP regulations and experience with quality record systems is essential.
- Must have demonstrated success inspiring staff in a fast-paced, goal-driven atmosphere.
- Must have demonstrated leadership of several teams along with an effective management style.
- Strong preference towards ASQ certification
KNOWLEDGE, SKILLS AND ABILITIES:
- Proven track record of effective management, supervision, and/or leadership of others' work
- Expertise in the execution, development, and improvement of protein-based immunoassays
- The capacity to handle difficult projects and meet deadlines while using logic
- Successfully convey difficulties, problems, and findings that affect the timeliness, accuracy, and dependability of laboratory data.
- Effectively convey performance expectations and goals
- Fostering teamwork and problem-solving techniques
- Outstanding communication skills (both oral and written)
- Expertise with the MS Office program
- Knowledge of common databases and data analysis tools (Excel, Access, SharePoint)
- The capacity for productive multitasking in a difficult setting with shifting priorities
- A successful track record in all prior projects.
- Self-motivated; eager to achieve high performance; competent to work both individually and in a team environment.
- Ability to facilitate meetings and follow up with resulting action items