Watertown MA based company who provides novel solutions to clients for advanced therapy process development and manufacturing which is establishing the first end-to-end manufacturing capability for mRNA is actively seeking (1) Director of Quality Control. This position is responsible for organizing and ensuring the successful operation of the Quality Control function at the Watertown, MA site. Responsibilities include oversight of the raw material, stability, EM, and in process and release testing programs. The ideal candidate will be an innovative leader with strong experience in QC lab operations.
Great location which has numerous attractions including dozens of excellent shopping spots, restaurants, museums, historical sites, colleges and much more. Located of the Mass Pike and their are plenty of commuter rail stops for commuters!!
location: Watertown, Massachusetts
job type: Permanent
salary: $185,000 - 200,000 per year
work hours: 8 to 4
- Planning and oversight of the QC lab operations including people management, team building, and ensuring client timelines are met while adhering to the defined QC budget.
- Coordination of outsourced lab testing while working on strategies to bring testing in-house, whenever possible.
- Subject matter expert in QC testing assays including both traditional and molecular methodologies. Interacts with auditors/clients during visits and tours.
- SME in assay qualification and validation design and execution including writing qualification protocols, coordinating the execution, and concise report writing.
- Build and oversee team of QC analysts through effective planning, mentoring, directing and coordination of GMP testing activities.
- Oversee the scheduling of raw material, in-process, release, and stability testing in a manner such that supports the manufacturing schedule.
- Responsible for maintaining the integrity of work areas including maintenance and calibration of equipment, general work center safety and cleanliness in compliance with established Quality standards
- Communicate and enforce laboratory quality requirements to all personnel working in the lab and ensure that they are completed per GMP requirements
- Create, analyze, verify, and approve data, results, reports, and certificates of analysis
- Generate, revise, review specifications, SOPs, and other QC lab and testing documents
- Lead Out of Specification and Deviation investigations related to the QC laboratory and ensure corrective actions are developed and implemented
- Lead and facilitate initial and periodic training of QC analysts to ensure adherence to laboratory practices, techniques, and GMP requirements
- Prepare and perform personnel evaluations and competency development and administer performance reviews.
- Hire, recruit, coach, and train employees
- Set short-term and long-term goals for the function that are aligned with company's goals.
- Continuously assess and ensure the appropriate structure is in place to support growth.
- Identify gaps and ensure the proper hiring and development of employees with the support of Human Resources.
- Set expectations, provide feedback and coaching, and take necessary action to ensure appropriate performance and goal attainment.
- B.S. or M.S. degree in a scientific field or related science discipline
- A minimum of 10+ years related experience with biological products in a QC lab
- Managerial experience required
- Technical and quality event writing experience in order to accurately depict program goals and execute root cause analysis and mitigation critical thinking.
- Must have experience with cGMP and quality systems including OOS investigations, deviations, change control and CAPAs.
- Requires excellent written and oral communication skills.
- High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines.
- Demonstrated ability to work independently as well as a strong contributor in a cross functional team environment on complex projects.
- Skilled at analyzing data, summarizing results, and generating performance metrics to drive corrective actions
- Strong work ethic with ability to meet rapidly evolving and dynamic business priorities
- Possess the ability to proactively adapt to rapid changes in business priorities and foster teamwork among employees to maintain high quality standards
- Ability to drive functional, technical, and operational excellence
- Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness
- Ability to manage timelines and coordinate work schedules of employees
- Direct supervisory experience strongly preferred
- Strong organizational and analytical skills; able to prioritize and manage through multiple complex processes/projects
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Detail-oriented and highly motivated with excellent written and verbal communication skills required.
- Ability to work independently and stay on task in a fast-paced environment without direct supervision.
- Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.
skills: Quality control, Quality Assurance, CAPA, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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