MSAT Site Lead - Athens
Job in
Spring Valley Estates, Clarke County, Georgia, USA
Listed on 2026-07-21
Listing for:
6062-Janssen Pharmaceuticals, Inc. Legal Entity
Full Time
position Listed on 2026-07-21
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
KEY RESPONSIBILITIES
- Lead a team of engineers owning portfolio products across the BU, managing lifecycle (LCM) and cleaning validation support, and monitoring and optimizing performance of small molecule drug substance (SM DS) products.
- Represent MSAT Athens in site leadership and in global SM DS leadership team meetings.
- Collaborate closely with Quality Assurance, R&D partners, Maintenance and Engineering (GET), and Operations to drive value within the BU.
- Provide technical support in partnership with Quality on regulatory audits and inspections and act as spokesperson for MSAT processes during internal and external audits.
- Lead and/or support complex process nonconformance events.
- Engage with global communities of practice and resources teams for process and cleaning validation, innovation, and data analytics to maintain high program compliance and implement new technologies and improvements.
- Partner proactively with the global Synthetics Platform to drive alignment, share knowledge, and deliver value through optimized collaborations.
- Minimum of a university/bachelor’s or equivalent degree is required; a master’s degree and/or a focused degree in Chemical Engineering or a related field is preferred.
- Required:
Minimum of 8 years of relevant work experience; demonstrated experience within a pharmaceutical manufacturing environment; strong understanding and knowledge of Quality & Compliance / regulatory requirements (GMP/EHS); strong expertise in chemical manufacturing processes, technologies, and products, as well as business acumen with synthetic drug substance; demonstrated experience managing, organizing, planning, and coordinating projects; demonstrated ability to effectively influence across all levels of the organization, build strong partnerships, navigate competing priorities, make autonomous decisions, and lead inclusive cross‑functional teams. - Preferred:
People‑leader experience building, developing, and leading high‑performing teams; strong understanding of business operations, with the ability to translate financial insights into operational decisions; experience with New Product Introductions (NPI) and/or technical transfers; demonstrated ability to drive innovation and continuous improvement to enhance operational excellence; experience applying Process Excellence and Lean manufacturing principles to improve outcomes; experience using data and analytics tools to identify insights and support decision‑making.
Other: May require up to 10% domestic and international travel. Requires the ability to report for off‑shift work and on‑call support, and must be available for other duties as required.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. Johnson & Johnson is committed to providing an interview process that is inclusive of applicants’ needs.
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