Head External Supply Europe (ESE) Quality Assurance (f/m/d)Apply Now Email Me Job ID R0006762 Date posted 01/16/2019 Location:Singen (Hohentwiel), Germany
Are you excited to collaborate in a multicultural team as part of a global pharmaceutical company? Do you have a passion for leading teams? We are searching for a Head of External Supply Europe (ESE) Quality Assurance (f/m/d)
Our Singen site in Germany is a center of excellence that is expanding rapidly. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. And we need bright, forward-thinking, ambitious and energetic people to support us on our journey. Almost 1,000 people are involved in the production and supply of 68 million vials, syringes and other products at Takeda’s Singen plant each year. Takeda’s production facility in the southern German town Singen, is located close to the Swiss border and has a key strategic role in our global manufacturing network. Our Global Manufacturing, Supply and Quality organization employs 7,500 people at 20 plants in 16 countries.
Why is a common day in Takeda and the area of Singen a highlight?
The atmosphere in Singen is really special: Start your daily work in a friendly, diverse and open-minded environment. You can spend your lunch break together with your colleagues in our own canteen or outside surrounding the green nature of our plant. After work you can use our company health program to do sports or enjoy the sunny days at the Lake of Constance. Fresh air and stunning countryside near the cool, clean water of Lake Constance will refresh your batteries for another day full of interesting challenges.
An attractive Compensation/Benefits package and unique development opportunities in a global expanding talent network makes Takeda a Top Employer.
What is the job about?
- Manages the QA Supplier Relationship Teams and release team to timely perform defined QA batch disposition activities, including EU Qualified Person certification. Ensures that critical changes and deviations associated with Takeda product are thoroughly evaluated with respect to regulatory compliance, product impact, and supply
- Champions the Quality Culture across the External Supply Team, aligning with the Takeda Global Quality Culture, and leveraging science, systems and people as key elements to ensure a site culture that focusses on Patients, Trust, Reputation and Business
- This position interacts frequently with Takeda Global Quality Assurance, Global Regulatory CMC and Development functions, Commercial affiliates, Supply Chain and Procurement, and external suppliers/contract manufacturers/license partners, and represents Takeda as necessary in Regulatory Authority inspections, and with industry groups
- Ensures that compliance and quality risks are communicated, understood, and mitigated, and are an integral part of business decisions, consistent with cGMP and Takeda Global Quality Standards. Performs product and vendor risk assessments as required
- Owns and monitors defined Key Quality Indicators, and takes action as necessary to drive improvements, and to assure the quality and compliance of product. Provides input into, and participates in, Quality Council meetings as required
- Participates in, and leads as required, audits of new and existing Takeda contractors and suppliers, including due diligence activities, and “for cause” investigations. Assesses the Quality GMP status of new External Supply managed contract manufacturers prior to approval for use and periodically thereafter
- Represents External Supply QA at meetings with Contract Manufacturers/ Suppliers as needed to ensure that Takeda requirements are met
- Participate in contractor/supplier meetings (on-site and via WebEx) as needed to support Quality and Business objectives
The preferred candidate has/is:
- Degree in Pharmacy, Chemistry, Biology or related subject
- Degree in Pharmacy and qualification as Qualified Person according to German Drug Law preferable but not essential
- At least 10 years’ experience in the Pharmaceutical Industry, including at least 5 years in a Quality related function, and at least 5 years of demonstrated leadership and accomplishments in a global, matrix organisation
- Extensive knowledge of Quality Assurance, compliance and auditing, and contract manufacturing in the pharmaceutical industry. Experience of sterile medicinal product manufacturing is advantageous
- Broad understanding of global Health Authorities requirements in the GMP and GDP regulated area; detailed knowledge of EU GMP, ICH, and other relevant regulations; and comprehensive working experience of the duties of the EU Qualified Person
- Strong analytical skills to accurately assess impact of proposed changes to existing processes, and to determine if and when quality improvements are needed
- Excellent intercultural communication, negotiation, and practical problem solving skills
- Fluent in English, spoken and written
- Willingness to travel internationally is required
Human Resources Germany
Robert-Bosch-Straße 8, 78224 Singen
Tel.: +49 7531-84 2108