Senior Specialist, Quality Assurance Operations

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description: 

Responsible for providing Quality Assurance (QA) support to Manufacturing, Quality Control, Process Development, Supply Chain and other teams (where necessary) for clinical manufacturing and testing both internally and externally (CMOs). Has experience in biotech or pharmaceutical (aseptically manufactured parenterals) cGMP environment.  Taking the key components and drivers from the commercial cGMP Quality model and fusing it with the flexibility and nimbleness needed to adequately control Quality in earlier through late Phases.

Experience: 

• BS/MS in a scientific discipline 
• 10  years experience in Quality Assurance in the pharmaceutical industry 
• Experience leading and writing root cause investigations and risk assessments in a cGMP environment, in multiple areas (DS and DP manufacture, warehouse, QC lab)
• Experience assessing and managing change controls and developing CAPAs 
• Knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical products, including drug products made through aseptic processing 
• Understanding of the drug development process
• Knowledge of cGMP principles with respect to US, EU, and other relevant regulatory guidance
• Proficiency with enterprise systems, i.e., documentation, LMS (learning management systems), deviations, CAPA, etc.
• Experience working with QP on batch review and product disposition 
• Ability to identify technical problems and suggest resolution of these issues 
• Strong collaboration and communication skills 
• Detail oriented coupled with sense of urgency 

Responsibilities:

Quality oversight of activities for facilities, utilities, equipment, systems and process with alignment and integration into the phase appropriate Quality Systems, including: 

• Review and approval of analytical method and equipment qualification/validation protocols/reports, environmental qualification protocols/reports, etc.
• Review executed batch records and QC raw data, close out reviews with internal or external parties 
• Review and guide investigations (deviations, OOS, etc), risk assessments, and CAPAs
• Review/approve operation support such as: standard operating procedures, user requirements, risk assessments, training materials
• Prepare lot disposition documentation
• Provide on-going Quality support for execution of activities. to ensure operations occur, according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. 
• Ensure facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations. 
• Develop training materials as needed
• Maintain day-to-day communications 
• Other duties as assigned

Key Skills: 

• Strong understanding of FDA and EMA cGMPs, GDP, 21CFR11, ICH and other applicable regulations 
• Critical thinking and experience leading investigations (deviations, OOS, etc), risk assessments, and CAPAs 
• Experience with method validation, working with a QP, aseptic processing, technology transfer and working with CMOs and contract labs
• Experience with aseptic processing and clinical supplies labeling/packaging operations
• Review and approval of controlled documentation such as: standard operating procedures, user requirements, risk assessments, training materials qualification/validation protocols/reports, environmental qualification protocols/reports. 
• Experience with Veeva Quality Docs and Veeva QMS preferred

Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.

We value our relationships with professional recruitment firms. To protect the interests of all parties and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.