Quality Regulatory Compliance Lead Vienna (f/m/x)
Job ID SR0054307 Date posted 09/20/2020 Location Vienna, Austria
Your (new) Opportunity:
- Supervision of the team members according to Business Ethics Takeda Corporation and continuous development (PMOs, training, mentoring, etc.)
- Motivation and encouragement of team members; balance workload among team members, strategic planning of department objectives in alignment with global objectives and procedures
- Representation of the Vienna plant in global projects and initiatives
- Responsibility for establishing and meeting HC and OPEX budget for Quality Compliance, Vienna
External inspections/audits (internal/customer) (30%)
- Planning, preparation, coordination, execution and follow-up of external inspections and audits (internal/customer); Overall inspection coordination
- Assess regulatory inspection results across Takeda plants and collaborate at cross-functional and global level to develop action plans
- Inspection Readiness: Maintain the plan, provide status update, identify key role plays, coordinate IR-assessments
- Develop strategies to systematically identify and address compliance gaps across the Vienna sites in close collaboration with the operating units
- Proactively monitor and review new and revised guidelines and regulations regarding safety and GMP (EU, FDA, ICH, China, Japan, Brazil and other key markets) and define implementation strategy and action plans in collaboration with plasma network
- Quality KPIs Preparation and moderation of the Vienna Quality Council and compile Vienna quality KPIs
- Develop PQR strategy in collaboration with global team for Vienna based products, monitor results and execution of improvement actions resulting from PQR reviews
- Establish and maintain Site Master File content for Vienna
- Define strategy for tracking and implementation of regulatory commitments
- Complaint Management (TAKEDA and CMO)
- Creation, review and approval of regulatory submission documents
- Quality interface between the Vienna site and the CMO business partner (Pfizer/Baxter) incl. managing inspections, quality agreements, events, complaints, etc.
Quality Projects (5%):
- Quality Project Management incl. reporting to senior management
Your Skills and Qualifications:
- Technical, pharmaceutical, chemical or biological college or university degree with practical experience of a quality operations function or related area
- 5+ years of management experience in the following areas in the pharmaceutical industry: Quality assurance, CAPA, change control, validation, management of regulatory inspections; understanding of the requirements for manufacturing, plant utilities, computer systems and project management.
- In depth knowledge of applicable regulations and laws for biological products, such as FDA CFR, cGMP, EU GMP, MD, EU Directives and guidelines
- Excellent change management and people management skills as well as strong communication and technical skills.
- Excellent command of the English and German language (verbal and written)
At Takeda, we are transforming the pharmaceutical industry through our R&-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work – life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer. For more insights into Takeda click here.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.
Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 4.439,- gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Job ID SR0054307
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