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POSITION SUMMARY:
The Manager, Quality Assurance leads a full range of Quality Assurance functions related to Halozyme’s rHuPH20 (ENHANZE) programs and management of systems supporting commercial products. These include but are not limited to; QA management of CDMO, batch record review, lot disposition, deviation/investigation resolution, SISPQ impact assessments, quality agreement compliance, annual product reviews, and change control management. This role is pivotal to the execution of Halozyme’s product and program objectives, and requires individual, team and department work product contribution.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include, but are not limited to:
QA Management of Contract Development and Manufacturing Organizations (CDMO)Review and approve Master Batch Records and review executed batch records for lot disposition
Critically assess out of trend, out of specification, deviation, and investigation reports for impact to safety, identity, strength, purity, and quality to support lot disposition,and resolve any issues to allow closure and the timely implementation of corrective actions
Ensure CDMO compliance with all applicable cGMP regulations, batch records and validated process
Ensure components, raw materials, starting materials, and third-party testing facilities are fit for the intended function
Ensure products meet all release tests and perform trending to confirm process consistency
Ensure products meet all IND/NDA/BLA/MAA (etc.) requirements as well as any partner requirements
Ensure product is stored and transported at appropriate temperature conditions and per validated or qualified shipper in coordination with third-party distribution sites
Review stability protocols and reports in compliance with annual stability commitments
Provide Quality input for process and method monitoring and annual product quality reports
Manage CDMO improvement efforts and initiatives and monitor Key Performance Indicators and Metrics
Drive internal process improvements with respect to Halozyme Quality Systems
Change Control FunctionGenerate, critically assess, and approve change controls in accordance with quality agreement requirements
Perform assessments of raw material changes, process/manufacturing changes, and equipment/utility changes with relevance to regulatory filings and quality agreements
Develop and execute change control implementation plans
Perform Quality Assurance activities associated with maintaining other internal Quality Systems such as:CAPA System (initiating, completing, and periodic updates, input into the management report)
Product Complaint system – investigation, trending as required
Perform Quality Assurance review and/or data verification audits on Halozyme or contractor documents
Contribute to the Quality Management Review process
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
Develop/revise/implement/adhere to departmental policies and procedures affecting Quality Assurance
Assist with maintaining file organization within the Quality department
Remain in compliance with Training program
Perform other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
Minimum of a Bachelor’s degree in a life science with at least 7 years’ experience in Quality/CMC for pharmaceutical, medical device or diagnostic industry (an equivalent combination of education and experience will be considered)
Thorough understanding of GMP regulations
Good writing and verbal communication skills
Ability to work independently and appropriately escalate to management, as needed
Skilled at relationship building and cross-functional collaboration
Good problem-solving skills
Attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents
Ability to multitask and work within a fast-paced dynamic team environment
TECHNICAL KNOWLEDGE REQUIRED:
Equipment:PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained.
Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint); experience with Veeva Systems preferred
INTERNAL AND EXTERNAL RELATIONSHIPS:
Maintain productive relationship and open communication with Regulatory, Manufacturing, Product Development, Research and Development, and Project Teams. Maintain productive and cooperative relationship with contract manufacturing, test organizations, and other contract service providers as required.
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities, if applicable:Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.
TRAVEL:
Travel may be required up to 15% of your time
