Ocular Therapeutix, Inc Sr. Manager / Associate Director Quality Assurance in Bedford, Massachusetts
This role is responsible for the development, implementation and maintenance of quality assurance systems and activities. Working closely with the Operations teams, this role ensures generation and review of documents used in good manufacturing practices are completed to the required standards and are current. Plays a lead role in ensuring investigations are conducted to the appropriate standard, resolve potential product quality issues, and make recommendations for improvement. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Management and continuous improvement of GMP Quality Assurance Activities and systems to ensure compliance to applicable guidance and industry best practices.
Provides direct QA oversight of the GMP batch record review, data review, and batch disposition processes
Manages QA Specialists to facilitate the batch review, data review, and batch release processes
Management of quality system records to ensure timely execution and closure aligned with internal procedures.
Maintains relationship and workflow with secondary packaging and labeling CMO to ensure timely batch record review and release
Dispositions products and approves COAs
Participates in investigations of deviations and product complaints
Evaluates the impact of planned and unplanned events on product quality and registered details.
Reviews and approves batch records, test methods, protocols and work instructions as required
Ensures compliance to internal SOPs and regulatory requirements
Supports regulatory and customer inspections as subject matter expert for batch record review, data review, batch disposition and quality systems.
Monitors internal audits and supplier audits and provide audit support as necessary
Monitors performance of quality systems and compiles documentation for quality and management reviews and annual product reviews
Assists in preparing and reviewing documents for regulatory submissions as needed
Provides QA review and approval of validations and change controls as needed
Innovation and Continuous Improvement:
Continually evaluates quality systems supporting GMP manufacturing operations for potential improvements.
Generates and presents GMP training to the GMP operations team on relevant topics
Generates and implements policies and procedures in support of the clinical and commercial manufacturing facility
Generates and evaluates trend reports and metrics to measure key quality attributes in manufacturing operations
Generates corrective and preventive actions from internal and regulatory inspectional observations
Ensures that effective corrective and preventive actions are instituted in a timely manner to prevent reoccurrence of quality events
Contributes to budgeting process and creates business cases as required.
Other duties may be assigned as necessary
- Bachelor’s degree in a Life Sciences discipline or equivalent
Minimum five (5) years of relevant experience in a regulated biotech or pharmaceutical industry
Minimum of two (2) years in a quality supervisory position performing Quality Assurance functions including batch disposition
Working knowledge of cGMPs, FDA regulations, and familiarity with the European Community guidelines for GMP
Working knowledge of drug development and strong knowledge of operations in an aseptic processing facility
Strong organizational and prioritization skills.
Strong technical and scientific written and verbal communication skills are required
Ability to effectively lead a team and work independently, within prescribed guidelines, or as a team leader or member
Demonstrated ability to follow detailed directions in a laboratory/manufacturing environment
Must be familiar with Microsoft Office applications
External Company Name: Ocular Therapeutix, Inc.
External Company URL: http://www.ocutx.com/
Street: 36 Crosby Drive