As a member of the Quality Control Raw Materials (QCRM) department, the Manager of Quality Control will be expected to facilitate and oversee the responsibilities relating to the sampling, testing, and inspection of all raw material lots received by the quality control raw materials department. These activities include Chemical raw materials, component inspection, and final packaging. The QC Manager is expected to support all day-to-day operations pertaining to QCRM including the mentoring, training, and career development of analysts.
- The QC Raw Materials Manager will build and grow the raw material program at Center for Breakthrough Medicines (CBM) including raw material testing and qualifications. Will partner with cross functional internal teams and with external partners to support raw material receipt, inspection, testing, and release for GXP use. They will be responsible for performing / ensuring inspection, sampling, testing, and labelling of raw materials. The QC Raw Materials Manager will require understanding of compendial requirements (USP, EP, JP, JPE, ACS, NF) as they relate to raw material identity testing.
·As product development occurs, the QC Raw Materials Manager will be responsible for the following activities:
- Develop and implement a risk-based phase appropriate raw material control strategy in compliance with applicable cGMP regulations.
- Author raw material specifications, including applicable identity tests in accordance with USP/EP.
- Perform inspection, sampling, testing, labeling and release of raw materials in support of GMP manufacturing and testing.
- Work closely with external partners to ensure that all raw material quality activities are performed in a timely and compliant manner.
- Identify and collaborate with contract testing labs to establish raw material test methods, investigate and resolve issues.
- Review data from external testing labs.
- Execute in-house raw material testing.
- Lead raw material qualifications and risk assessments as needed
- Drives on-time closure of all quality events and tasks for QCRM
- Act as subject matter expert (SME) for specified functions within QCRM.
- Provide leadership to the QCRM group that includes promoting development, timely communication and fostering an open and positive teamwork environment
- Promote and act as the continuous improvement champion within QCRM
- Act as liaison between QCRM/other departments to communicate release schedules
- Bachelor’s Degree with 6-8 years relevant experience in a cGMP Quality Control department within an FDA regulated industry
- Strong customer service orientation.
- Experience with leading matrix teams
- Strong analytical and technical background in compendial testing and related equipment, including wet chemistry, FT-IR, UV/VIS, KF, Titration, and GC methodologies.
- Experience in raw material inspection and testing practices.
- Experience leading and facilitating quality events including OOS investigations
- Strong technical background and familiarity with laboratory control operations and quality systems
- Experience with inspections/audits by FDA and other regulatory agencies
- Experience with lab and data management systems (LIMS, Empower,etc.)