Senior manager Drug Product & Compliance (X/F/M)

The Chemical Production facility in Geel, Belgium is part of the Janssen Supply Chain organization within Johnson & Johnson and is the largest manufacturer of active pharmaceutical ingredients (APIs) and spray dried powders (SDP) within the network. Spray drying is the first step in the Drug Product manufacturing and therefore treated as a Drug Product intermediate (DPi). The APIs/SDPs are then sent for further processing through pharmaceutical production into tablets, ointments, syrups and other formulations.

The Senior Manager Drug Product SME and Compliance role has 3 major responsibilities: the Operations lead expert for Drug Product , lead spokesperson for Operations in governmental and J&J audits, and support of Operations in risk and compliance management. Operations includes the chemical plants, the powder handling unit and the teams reporting into these.
 

Working in partnership with multifunctional groups and collaboration with the business across departments, with other internal and external partners is a crucial aspect to this role.

Solid understanding of spray dry manufacturing and knowledge of process technology is preferred. Good understanding of API manufacturing is key.

Duties and Job Responsibilities:

• Site lead authority in spray - and post drying . This means:

  • Accountable for all site spray dryer and post dryer related projects
  • Providing & further growing needed expertise- defining & ensuring needed spray and post drying competencies for all the different functions on site
  • Continuously exploring the market for future improvements in spray & post drying technology and in Process performance and Data Science
  • Supporting the Business Unit Lead in strategic and tactical capacity management, in New Product introductions on Spray & Post drying technology, Risk management
  • Contribution to SDP technical documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc.)

• Lead Spokesperson for Operations in Governmental and internal audits:

  • The site has multiple audits and Operations is a key player in these. This person will be primary spokesperson during site tours, interviews, and will explain the Operations structure, key business processes, the way we function from a Safety, Quality and Delivery perspective, how investigations took place,…

• Operations Support role:

  • Multiple activities are needed to support the team strategically, tactically and day2day. These are intended to ensure compliance and risk management within the Operations team.