Head Ouality Unit, Qualified Person AMG 15.3/3a, Director Site Quality, Director Quality Assurance

* Member of the Leadership Team
* Main site activities. Supply of generic drug product
produced by contract manufacturers to the German
market

Principal Responsibilities:
* Lead the site Quality Organization
* Main quality contact person for Health Authorities
(Regierung von Oberfranken)
* Ensure a timely batch certification and release of products
manufactured by CMOs located in the EU and worldwide
* Ensure a timely import testing of products originating from
CMOs located in non MRA countries
* Ensure all prerequisites from a quality perspective are
fulfilled to facilitate on time new product launches, in
particular day one launches
* Generate a continuous improvement culture with the Quality
Unit
* Increase the efficiency and performance of the Quality Unit
by fostering a culture mindset change towards a scientific
and business oriented thinking
* Continuously improve the quality system and the compliance
level of the company
* Assure inspection readiness of the company
* Responsibility for the budget of the Quality Unit

Personnel responsibilities
* Direct reports (9):6 team leads of the single Q units, scientists
with an university or technical degree college degree, plus 3
Qualified Persons
Personnel responsibility for overall 70 employees

Qualified Person for Vaccines (§15(3) AMG)
Wasserburger Arzneimittelwerk GmbH, a company of the
Recipharm group

* Member of the Site Management Core Team
* Deputy to the General Manager
* Member of the Recipharm Corporate Quality
Management Team
* Member of the Recipharm Sterile Quality Team
* Main site activities: contract development and
manufacturing of sterile lyophilised and liquid drug
products, including vaccines, containing large and small
molecules as active ingredients

Principal Responsibilities:
* Lead the site Quality Organization
* Qualified Person for vaccine products
* Generate a continuous improvement culture with the Quality
Unit
* Increase the efficiency and performance of the Quality Unit
by fostering a culture mindset change towards scientific an
business oriented thinking
* Main quality contact person for Health Authorities and
Customers
* Drive the acquisition of new business in close collaboration
with the General Manager
* Create the necessary basis and conditions to embark on
business opportunities from a scientific and regulatory point
of view
* Continuously improve the quality system and the compliance
level of the site
* Assure inspection readiness of the site and lead important
audits and inspections
* Define and drive the strategic direction of the site in
cooperation with the other management core team
members
* Responsibility for the budget of the Quality Unit

Personnel responsibilities
* Direct reports (6): managers of the single Q units, scientists
with an university or technical degree college degree
* Personnel responsibility for overall 80 employees

* Lead the Quality Assurance resources at the Schaffhausen
site
* Main site activities: fill / finish of sterile, liquid or
lyophilised parenteralia containing biochemical entities
* Ensure Quality standards are reliably maintained and
comply with J&J global guidelines and regulatory
expectations.
* Provide quality and compliance guidance and leadership to
the related operational units.
* Ensure that effective systems, measures and reporting are
in place for monitoring and controlling the related GMP
activities.
* Lead inspections of the local and global health authorities
(incl. FDA)
* Responsibility for the performance and development of the
Quality Assurance associates.
* Manage QA lead times to ensure a timely product
disposition.
* Drive continuous improvement holistically in the
department and for quality topics on the entire site.
* Ensure sufficient and appropriately trained QA resources
are deployed.
* Budget (headcount, expenses, CAPEX) responsibility for the
QA department (~ 7 Mio €).
* Initiate quality escalations and lead escalation meetings.


Personnel responsibilities
* Direct reports (five): managers of the single Q units, scientists
with an university or technical degree college degree
* Personnel responsibility for overall 50 employees

* Ensure complaint investigations are thorough, timely,
and compliant to internal and external regulations and
standards.
* Oversee global complaint investigation activities
associated
* Main products in scope: Combination products and drug
products containing biopharmaceutical entities as active
ingredients.
* Develop, implement, and maintain effective and efficient
processes and systems to achieve metrics and goals.
* Partner closely cross segment with complaint vigilance
and complaint investigation groups to both align on best
practices and to ensure smooth handover of cross
segment complaint handling activities
* Work in close partnership with Commercial Operation
entities (Manufacturing sites, Customer Service, R/D,
Regulatory, Legal, Quality, etc) in resolving customer
issues and developing continuous process improvement
initiatives.
* Serve as the Post Market Complaint Investigation expert
during all internal and external audits and inspections
* Oversee post market complaint investigation crossfunctional
team meetings, and present complex data to
Executive staff members.
* Reviews and recommends product actions based on
complaint investigation data to include initiation of
requests for CAPA or escalation for consideration of
quality holds, post market risk evaluations, etc.
* Work closely with manufacturing complaint labs and
provide support for complaint investigations.
* Continuously evaluate effectiveness of pertinent post
market quality systems to determine gaps or areas for
improvement; convey results of assessments with
appropriate actions to management.
* Periodic review of global complaint data and trends

* Personnel responsibility for a globally dispersed team of
24 people

* Member of the Site Management Board
* Member of the Extended Janssen Supply Chain Quality
Leadership Team
* Member of the J&J Aseptic Processing Council
* Member of the IDV CMC Council and Specification Setting
Board
* Main site activities: production of biological active
ingredients for vaccines and drug products

Principal Responsiblities:
* Lead the site Quality Organization
* Continuously improve the compliance of the site and advise
the site and the JSC management of potential risks
* Assure inspection readiness of the site
* Actively collaborate with JSC Q partners to assure consistent
application of best practices
* Generate a continuous improvement culture to improve the
efficiency of the Quality Unit by increasing the scientific and
the business acumen.
* Responsibility for a budget of approx. 8 Mio €
* Represent the site in all Quality topics both internally within
Janssen and externally towards affiliated companies,
customers. and Health Authorities
* Act as the Responsible Person
* Define and drive the strategic direction of the site in
cooperation with the other SMB members

Personnel responsibilities
* Direct reports (five): managers of the single Q units, scientists
with an university or technical degree college degree
* Personnel responsibility for overall 60 employees

* Provide leadership and support for development,
deployment and maintenance of strategic compliance
requirements to the assigned Janssen Supply Chain sites
* Lead the core compliance support activities for JSC
pharmaceutical production activities in EMEA and APAC
in close cooperation with Enterprise Regulatory
Compliance and the Quality Assurance Directors and
Managers in the region
* Ensure compliance programs are implemented and
maintained at the sites in the EMEA / APAC supply chain
* Cooperate with business partners to mitigate compliance
risks and to manage Health Authority inspections
* Partner with peers with the Pharmaceutical and the
Enterprise Regulatory Compliance organisation for
consistency and leveraging needs

* Aseptic manufacturing of sterile drug products containing
biopharmaceutical active ingredients
* Manufacturing of non sterile drug products containing
chemical entities as active ingredients
* Manufacturing of non sterile, chemical APIs

Organisatonial responsiblities:
* Lead the Quality Control Resources within the Cilag AG
including
* testing of finished product (drug products both
biopharmaceuticals and small molecules, APIs)
* microbiological testing
* testing of raw materials for pharmaceutical and chemical
production
* testing of packaging material
* Drive continuous improvement and implementation of Lean
methodologies and culture in the labs
* Responsibility for a budget of approx. 13 Mio €
* Member of the Site Quality management board
* Member of the extended Pharma Management board
* Represent the site in QC topics both internally within J&J and
externally towards customers

Personnel responsibilities
* Direct reports (seven): managers of the single QC units,
scientists with an university or technical degree college
* Personnel responsibility for overall 140 employees.

Organisatonial responsiblities:
* Lead the Quality resources within the Pharma Business Unit,
including QA & QC functions
* Member of the Site Ouality Management board
* Member of the enlarged Pharma Management board
* QA / QC site representative in international project teams

Personnel repsonsibilities
* Direct reports (four): managers of the single QA and QC units,
scientists with an university or technical degree college
* Personnel responsibility for a team of overall 65 employees.

Organisatonial responsiblities:
* Incoming testing of materials and release testing
intermediates and finished products (solida)
* EU market release testing of products manufactured within
BI but outside EU (liquida)
* QC member in the site PAT team
* Member QC operation in product development teams
* Repsonsibility for the budget of the quality control unit

Personnel repsonsibilities
* Direct reports: scientific and admin assistant (pharmacist),
coach of the team lab technician team, key user LIMS system
* Personnel responsibility for a team of overall 27 employees

* Design and installation of a line for aseptic filling of enteral
nutrition and packaging under clean room conditions
* Qualification of the machines and the clean room area
* Validation of the manufacturing process
* Coordination of the internal departments (R&D, marketing,
production, qulity assurance, quality control) involved in the
NutriBag project
* Communication to the customers concerning all NutriBag
relevant aspects, investigation of customer complaints