QA Technical Operations Lead

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 unlock the power of gene therapy to accelerate healthcare transformation.

We don't follow footsteps. We create the path.

The Sr. QA Technical Operations Specialist will be responsible for providing data integrity oversight along with regulatory guidance for implementing GMP/GCP/GLP systems throughout the system lifecycle, including the planning, implementation, execution, operation, and retirement of systems throughout the company. The incumbent will require ensuring compliance with company policies, SOPs, and regulatory requirements and guidance supporting all world health authorities for all GMP/GCP and GLP computerized systems.

The role will require supporting project teams for new computerized system implementation, support for capital projects, review and approval of system lifecycle documents, review, and approval of SOPs, and performing the review and approval of deviations, CAPAs and Change Control. Seniority within the team will be dependent on subject matter expertise and may require direct people management.

Responsibilities (to include but not limited to)

Job Function and Description• Provide oversight for the governance, management and coordination of activities related to the data integrity including implementing and maintaining data integrity compliance activities across the end-to-end product lifecycle and across all internal functions in alignment with relevant governmental regulations and guidelines. • Perform review and approve system lifecycle documentation for new and existing equipment, utilities, facilities, and analytical instruments including URSs, validation plans, qualification summary reports and requirement traceability matrices. • Develop, review, approve, provide inputs to processes, policies, SOPs required for data integrity governance and implementing GMP/GCP and GLP computer systems in compliance with major health authority regulations and internal processes.• Provide independent quality review and approval of key qualification/validation documentation for data integrity and computer system implementation.• Support regulatory inspections and audit activities of computerized systems.• Participate in project team meeting as the QA representative, providing input on current industry practice and regulatory expectations.• Drive continuous improvement and assist in resolving compliance related events.• Provide oversight and guidance to junior level staff members and project-based QA contractors in support of capital projects and quality initiatives.• Collaborate with key stakeholders, business owners, system owners and IT to assess and select computer systems to ensure technologies meet high level business needs.• Provide guidance to ensure all systems have quality approved operating level procedures and plans to maintain validated status of computerized systems. • Support capital projects as required.

Education and Experience Requirements

• BS / BA in Biology, Chemistry, Engineering, related life science, or equivalent industry experience is required.
• Generally, 5-12+ years of experience in the Pharmaceutical/Biotechnology industry.
• Must have proven advance experience working in a GMP environment.
• Advanced process and equipment experience and/or knowledge in the areas of biologic drug substance, drug product, aseptic fill, finish, and packaging operations.
• Advanced knowledge of global regulations with emphasis in 21 CFR Part 11, 58, 210 and 211.
• Strong experience with regulatory inspections.
• Advanced knowledge of GMP compliance as well as USP, EP, ICH, and FDA guidelines.
• Ability to influence organizational functions.

Key Skills, Abilities, and Competencies

• Broad knowledge of quality systems such as change control, investigations and CAPA.
• Ability to communicate effectively with wide range of personnel.
• Solid technical writing skills related to investigation reports.
• Strong analysis and problem-solving skills, including, but not limited to, the ability to review and analyze validation data.
• Ability to lead and participate on cross-functional teams in root cause analysis and solution identification.
• Ability to demonstrate strong project management focus as well as focus on execution of strategic decisions while balancing conflicting priorities.
• Demonstrate strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.
• Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.

Complexity and Problem Solving

• Ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.
• Strong critical thinking to analyze complex situations and discern critical issues.
• Ability to manage competing priorities.
• Ability to interact effectively with health authorities and various Spark stakeholders.

Internal and External Contacts

• Frequent internal company and external contacts that include QA, QC, IT, CMC, Manufacturing and Validation.

Other Job Requirements

• The ability to travel approximately 20%, domestic and international
• This position may require occasional shift work, including weekends, off hours and holidays as needed.

Spark takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $110,200 to $165,400.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.