The primary responsibilities include the following:
Work closely with Quality, Manufacturing, Facilities, Materials Management, Supply Chain Functional Management to identify strategies, tactics, and objectives for product quality and GMP compliance.
Participate in internal audits as needed to assess compliance with approved operating procedures, policies and GMP regulations.
Review/Approve/Write/Revise Standard Operating Procedures, Work Instructions, Policies, Protocols, Reports related to departmental activities.
Generate trending reports to update Functional Management on GMP Compliance status
Generate industry benchmarking reports
Manage receipt, tracking and investigations of product complaints
Manage the Quality Technical Agreements Program
Participate in inspection preparedness to maintain inspection readiness
Work closely with Functional Management to provide Quality Compliance support for all areas and processes and participate in the maintenance of overall compliance status of all GMP operations
Training responsibilities may include the following:
Manage training requirements for newly hired FTEs and contractors
Collaborate with functional managers and training coordinators to develop and / or update GMP training requirements to include position-based curriculum.
Maintain training records for GMP employees and contractors (paper and electronic)
Maintain the electronic Learning Management System
- Conduct internal audits
- Process periodic reviews of existing Quality Technical Agreements and initiate the process for new agreements
- Work with the various departments in collecting metrics of critical operations and generate trending reports for cross functional review
- Support receipt and processing of product complaints
- Assist in regulatory site and virtual inspections preparation and maintenance of inspection readiness. Participate in regulatory inspections and related follow up activities. Generate required documentation for regulatory inspections & partner audits.
- Support the process for Annual Product Reviews. Review and ensure the content is accurate & meets requirements for the review period.
- Assist with annual mock recalls
- Participate in implementing key improvement initiatives and help solve compliance issues while partnering with business & process owners.
- Provide quality input on a variety of compliance related issues and attend meetings as the QA compliance representative.
- Conduct new hires required GXP training and assign training requirements in the Learning Management System.
- Work with individual department leads to develop job specific training metrics
- Other assigned responsibilities as established by QA Compliance Lead.
Education and Experience Requirements
- BA/BS in scientific discipline required or equivalent work experience
- A minimum of 7-10 years in a global pharmaceutical/biotech manufacturing environment with exposure to Quality and Manufacturing areas
- Broad working knowledge of relevant governmental regulations, cGMP and guidelines (US, EU and other territories where Spark products are distributed), and ability to organize cGMP procedures based on regulatory / compliance regulations
Key Skills, Abilities, and Competencies
- Knowledge of domestic & international CGMP Regulations
- Quality Management Systems (Change Control, Deviations, CAPAs)
- Familiarity with 21CFR parts 11, 210, 211 and 820
- Ability to communicate effectively with wide range of personnel
- Solid technical writing skills
- Ability to organize cGMP system procedures based on regulatory / compliance regulations
- Must have strong attention to detail
- Strong analysis and problem-solving skills
- Ability to lead (as necessary) and participate on cross-functional teams in root cause analysis solution identification and compliance
- Proficiency with computer systems
- Experience in regulatory inspections
- Ability to work in a dynamic, fast paced environment with shifting priorities
- Knowledge of Learning Managements Systems preferred but not required
- Knowledgeable and capable in the following areas:
- cGMP & FDA.EMA.MHRA biologics, cellular & human gene therapy regulations preferred but not required
- Production of human gene therapy products preferred but not required
Complexity and Problem Solving
- Develop solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.
- Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive working relationships internally and externally.
- Works under minimal supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.
- Contributes to the completion of organizational projects and goals.
- Ability to establish facts, define problems, collect data and draw valid conclusions.
- Ability to work collaboratively in the process of problem solving of any issues related to the quality systems processes
- Ability to be assertive to ensure conformance to cGMPs while maintaining a collaborative environment
Internal and External Contacts
- Peers and colleagues throughout the organization.
- External contacts such as suppliers, partners.
- Represents organization on specific projects.
Other Job Requirements
- The position may require occasional weekend work, off hours and holidays as needed.
- Occasional travel (less than 10%)
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.