Senior Manager, Quality Control
Location: Bedford, MA
The Quality Control Manager is responsible for managing all microbiological and physico-chemical testing of production materials under GMP conditions. The position is responsible for the development, implementation and maintenance of QC systems and standards, including the environmental monitoring program.
Strategic Focus Areas:
- Provide leadership for quality control activities and improvement initiatives within assigned functional areas
- Optimize resources within Quality Control to ensure timely maintain compliance standards and cost discipline
- Design, implement and participate in projects and activities which support the growth of the company
- Cost reduction and improved efficiency through the elimination of waste and streamlining QC test methods
- Provide direct management of all activities required for the testing and release of commercial products in a cGMP environment to include:
- Testing and approval of raw materials, in-process samples, bulk and finished products
- Environmental and personnel monitoring
- Stability samples in conformity to standards and approved specifications
- Drive and perform timely review of complete release testing and stability data for the raw material and finished product batches.
- Participate in lab audits and lab investigations related to OOS & other deviations along with QA colleagues.
- Follow good documentation and review practices, and effectively communicate scientific results and strategies in presentations and written reports.
- Maintain knowledge of and critically evaluate quality and compendial literature and industry trends.
- Review stability reports to ensure compliance with regulatory and annual reporting requirements
- In collaboration with R&D and Engineering staff, support development and validation of new test methods; optimize and improve existing test methods
- Establish and/or approve changes to QC processes, materials and specifications
- Evaluate systems and recommend corrective actions to assure conformity with quality specifications
- Critically evaluate scientific data and study protocols, will lead initiatives, and take part in, and lead cross-functional teams. In addition, this individual will be a stakeholder in ensuring that analytical methods and data are fit-for-purpose.
- Establish QC metrics/key performance indicators to manage laboratory performance and to present at the management review meeting; develop recommendations to improve performance
- Develop and manage budgets for staff and equipment and monitor expenditures
- Develop and execute staffing and resource plans to meet QC requirements for company; develop MBO’s for the group that support company Objectives
- Provide for the training and development of staff; establish training curriculum and perform staff evaluations
- Responsible for other duties and projects as assigned
The Quality Control Manager exercises considerable judgment within generally defined practices and policies. Erroneous decisions or failure to act could cause critical delays in schedules and impact business activities. The Quality Control Manager interacts with peer groups, senior management and external customers to advance company goals.
The position supervises exempt and non-exempt personnel in the execution of daily activities. The position is responsible for technical staff in the Chemistry and Microbiology sciences.
- Bachelor’s degree in Chemistry, Microbiology or Biology
- Minimum of 10 years of experience in a regulated QC biopharmaceutical or Medical Device industries
- Previous experience within an aseptic facility or with aseptic sterilization techniques
- Minimum of 5 years supervisory experience
- Proven experience with technical writing skills to draft documentation, preparing technical reports, memos and protocols.
- Adept at building and developing teams
Desired Experience, Knowledge, and Skills:
- Master’s degree in the life sciences preferred
- Knowledge of ISO standards as well as FDA and EU requirements
- Ability to work autonomously, effectively manage time and deliver results on time
- Excellent presentation skills, both written and in platform presentation format
- Acts decisively and seizes accountability
- Holds team members accountable
- Embraces and leads change
- Adept at building and developing teams
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.