Head of Quality Control (QC)

Organization
Spark Therapeutics
Job Location
Philadelphia, PA
Job Description

The head of quality control (QC) will provide overall strategic and tactical leadership for the QC laboratory and personnel. He or she will ensure proactive GXP compliance and will interact with customers, contract laboratories, auditors and regulatory agencies. He or she will be responsible for the development of qualified staff to ensure effective testing, execution of roles and responsibilities, GXP compliance and attainment of operational and development goals. 

RESPONSIBILITIES: 

Interface with development, regulatory, quality, manufacturing and technical services organizations 
Actively participate in meetings where laboratory input is needed and encourage interdepartmental communication 
Develop short and long term goals of QC laboratory efforts in support of regulatory submissions, clinical efforts, commercial product supply and program-driven milestones 
Establish, communicate and sustain metrics to monitor lab performance and compliance 
Report and present in management meetings as appropriate. 
Supervise and coordinate QC personnel and oversee daily quality testing method qualification/validation and USP/EP/JP/BP method verification activities to support the development and manufacture of drug products 
Review and author as needed qualification-validation protocols for testing methods developed 
Implement quality testing procedure’s qualification-validation 
Write method qualification-validation reports or other technical reports 
Supervise and as needed, approve test data, qualification/validation/verification data, qualification/validation/ verification protocols, and qualification/validation/verification reports 
Implement a raw material testing program initially utilizing contract testing laboratories 
Work with manufacturing to put in place an environmental testing program that will meet the standards of commercial manufacturing; this program will initially be a combination of in-house and contract testing 
Provide tech support to quality during audits of raw material manufacturers and/or contract testing laboratories 
Ensure safe and compliant laboratory environment 
Support agency inspections 
Provide lead escort role in all audits involving the QC laboratory 
Responsible for laboratory capacity planning in order to anticipate commercial production scale up, and continued assessment of resources in order to meet current and future state demands 
Oversee and communicate laboratory resources 
Develop and sustain the laboratory reference standard program and partner with contract laboratories to ensure the same as appropriate 
Provide leadership in areas of all phases of investigation, communication, and resolution into failures, deviations, and aberrant results – including development of OOS program and the implementation of a release testing trending system 
Identify and implement a LIMS systems in line with the stage of development of the organization 
Revise and update standard operating procedures as needed 
Author high level policy documents 
Perform other related duties as required 
Author required CMC sections of regulatory submissions 
Review documentation prepared by staff for regulatory submissions 
Manage QC technical personnel

Requirements: 

QUALIFICATIONS: 

Experience writing applicable sections of regulatory filings 
Demonstrated technical project management experience to develop project goals, deliverables and timelines 
Knowledge of continuous improvement such as total quality and statistical process control 
Strong knowledge of GXP compliance as well as USP, EP, ICH and FDA guidelines 
Expertise in developing and setting product specifications 
Knowledge of relevant compendia, chemical/microbial/biological assays and general lab equipment 
REQUIREMENTS: 

M.A. or M.S. in biology, biochemistry, biotechnology, chemistry, microbiology or related field required, PhD preferred, experience with vaccines a plus 
Minimum 12-15 years of experience in the pharmaceutical industry, with 8-10 years in a supervisory or lead role

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