Proclinical is currently recruiting for a QA Manager with a pharmaceutical company located in Burlington, MA.
- Assist the Head of Quality Assurance with the development, implementation, optimization and strict adherence to a quality assurance program which meets the most up-to-date regulatory requirements and the global quality directives. Develop and/or review and/or approve standards, policies, and procedures for all functions and departments involved with or related to the production and testing of all materials, as assigned.
- Develop and motivate Quality Assurance staff to effectively carry out department functions; provide leadership, guidance and direction of staff consistent with cGMP and company corporate quality objectives. Coach and mentor staff in all aspects of their job performance and career development including training, feedback and disciplinary action. Ensure that the staff has a full understanding of department processes and procedures.
- Manage the disposition of all raw materials, intermediates, packaging and factory supplies, and all finished goods for commercial and clinical operations.
- Manage the Quality Events Management System for deviations, failure investigations, out of specification/out of trend investigations, calibration out of tolerance events, CAPAs and CAPA effectiveness monitoring. Ensure that all Quality Events are completed in the time required by company procedure and that all investigations are completed in a thorough manner to appropriately identify root cause and corrective/preventative actions. Authorize critical deviations and provide guidance and troubleshooting during investigation.
- Manage all customer complaints and recalls. Authorize material returns and destruction, including recommendation of corrective action plans/programs for overall defect reduction
- Report serious or repeated failures or unreliability in quality of products to Head of Quality Assurance.
- Manage the preparation and approval of master batch records, cleaning batch records, monographs, and test methods. Review and oversee implementation of change notices and related document change control. Manage the issuance of production batch records, equipment log sheets, and log books.
- Manage the review of all manufacturing and test documentation to assure conformance to quality standards including the review of production and cleaning batch records, shipping records, stability protocols, pest control activities, testing and inspection records, and customer contract specifications.
- Approve master item number data and changes, as well as finished good labels.
- Authorize reprocess, rework, disposal or return to vendor decisions. Approve inventory adjustments.
- Participate on cross functional teams and quality global inter-site initiatives representing the site Quality department, as assigned.
- Manage and participate in the QA on-call rotation. Prepare, review reports and other documentation required by regulatory agencies to support the quality assurance function.
- Provide support during regulatory inspections and customer audits. Assist in performing inspection readiness activities and supplier audits. Lead the site supplier qualification initiative and maintain approved supplier list for the site
- Responsible to liaise with site subject matter experts on the review of gap and risk assessments for global quality standard implementation, this role will also be the quality subject matter expert in determining implementation plans for global standards
- Site Quality subject matter expert on Site Quality Management reviews to support the site leadership in driving continuous improvements
- Set up training program for manufacturing quality oversight in manufacturing areas
Skills and Requirements:
- Minimum Bachelor of Science in Chemistry or a related field
- Minimum five years' QA, RA experience in pharmaceuticals or a related cGMP regulated industry
- Minimum two years supervisory experience or coach/mentor role
- Broad knowledge of cGMP, FDA and international regulations (e.g., 21 CFR 11, EU GMP, ICH Q7), Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH).
- Knowledge of pharmaceutical processes to be able to make appropriate decisions.
- Strong attention to detail is required.
- Strong interpersonal, written and oral communication skills.
- Excellent communication and collaboration skills and demonstrated ability to work cross functionally across internal stakeholders.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.