The Lead of Quality Operations has responsibilities for the Quality Operations support function teams including the oversight of QC Laboratories systems, the QC Sample Management program, QC Documentation management & review, Stability sample program management, and the QC External Contract Testing Laboratories program. The incumbent will ensure GMP compliance and have direct interaction with auditors / regulatory agencies as well as accountability for the development of qualified staff to ensure the execution of roles and responsibilities for the operational goals of the subject team.
The Lead of Quality Operations will be a key leader on the Quality Control Operations Leadership Team and partner with their co-leads in QC Testing as well as cross-collaborate with Analytical Development, Analytical Sciences, and Analytical Program Development & Management to manage and develop strategic QC Operational processes and initiatives to develop new way of working, drive continuous improvement projects, and well as oversee key QC operational functions as mentioned above. This role will also closely interact with Manufacturing, IT, QA, Technical Operations, CMC, and supply chain.
The Lead of Quality Operations must have a strong background in Quality Control Laboratories and systems such as SAP, GLIMS, and/or EMPOWER with people management experience in a commercial environment. Experience working with external contract laboratories, vendors, and other external entities as well as working in R&D or commercialization is strongly desired. A strong background in Lean/Sig Sigma is desired.
The Quality Control Operations Lead will:
- Oversee key support functions and associated the teams for Quality Control Operations including the QC sample management, GMP documentation review, stability program management, GMP laboratory systems, and external contract laboratory testing oversight
- Develop, align, and improve the processes and procedures for and within these key support functions / teams for the QC Operations areas to support the QC testing laboratories and the Analytical Development, Analytical Sciences, and Analytical Program Development & Management Teams
- Identify and execute key strategic projects, systems, and opportunities for improvements in the ways for working in the QC Operations area to improve productivity and capacity for QC testing operations
- Collaborations with fellow QC Leads and stakeholders for GMP testing investigations and deviations
- Will support internal and external audits and inspections
- Will review and approve GMP qualification/validation reports, investigations, technical reports, and other associated documentation for the area’s function
% of Time
Job Function and Description
Manage and lead the team for Quality Operations which include the key support functions: QC sample management, GMP documentation review, stability sample program management, GMP laboratory systems, and external contract laboratory testing oversight
Develop, align, and improve the processes and procedures for and within these key QC Operations areas to support the QC testing laboratories and the Analytical Development, Analytical Sciences, and Analytical Program Development & Management Teams
Identify and execute key strategic projects, systems, and opportunities for improvements in the ways for working in the QC Operations area to improve productivity and capacity for QC testing operations
Manage the Quality Operations Team which includes: QC Systems, QC Sample Management, QC Data Review, and QC Outsource Contract Testing leads & team members to achieve business goals and objectives.
Education and Experience Requirements
- Foster Spark’s Culture. Role model the Spark Values. Create an environment where team members thrive by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.
- Hire & Integrate. Know what skills, experiences and capabilities are needed to achieve current and future business goals. Take an active role in attracting and selecting talent who are inspired by our Mission, Vision and Values. Consciously create a team with diverse backgrounds, experiences, skill sets and perspectives. Help new team members successfully integrate into Spark so they can actively contribute and add value as quickly as possible.
- Manage performance. Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing. Provide team members with continuous and on-going performance feedback, holding everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by continuously communicating priorities, decisions and changes; adjusting goals as needed.
- Develop people. Understand each individual team member’s career goals. strengths and motivators. Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning and stretch opportunities.
BA/MA/MS degree required in Chemistry, Biochemistry, Biology, or related discipline
Key Skills, Abilities, and Competencies
- Generally, 8-10 years of relevant experience in the biotech and/or pharmaceutical industry of progressive responsibility in biologics and/or gene therapy (or related) analytical roles with 3-5 years in a supervisory or lead role.
- Must have proven experience managing in cGMP/QC laboratories environment
- Experience with regulatory agencies and/or auditing is required
- Demonstrated abilities in project management, process development & continuous improvement, and change management. Lean/Six Sigma expired is preferred.
Complexity and Problem Solving
- Background in method development or QC testing
- Fundamental understanding of methods used to support rAAV Gene Therapy products
- Demonstrated ability to hire & integrate new talent into the organization, manage performance, develop people, and model the company’s values & culture
- Energetic and eager to manage multiple activities, priorities, and direct reports
- Strong team player who works closely and effectively with colleagues
- Excellent interpersonal, written and verbal communication skills
- Strong organizational skills
Internal and External Contacts
- Demonstrated capability to think strategically and execute a plan of action based on a clear vision
- Must be able to critically assess unclear, unexpected or conflicting results and guide a path forward.
- Must be able to exercise good judgement to determine appropriate action including when discussions with manager or collaborating groups are needed
- Needs to be comfortable in a fast-paced environment and be able to interact with multi-disciplinary teams at Spark
Internal: MS&T, QC, PD, AD, AS, QA, Regulatory
Vendor: Contract Testing Laboratories
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.Learn more about Spark Therapeutics and view other openings.