Senior Quality Assurance Manager
1 week geleden
The Role:
We are seeking a highly skilled and experienced Quality Assurance Senior Manager to join our team at Deciphera Pharmaceuticals. As a Quality Assurance Senior Manager, you will play a key role in ensuring the quality and compliance of our medicinal products in the EU, Switzerland, and UK.
Key Responsibilities:
- Coordinate quality assurance activities within the local organization to ensure compliance with legal regulations and company procedures.
- Act as the primary contact for quality assurance enquiries and support global quality assurance initiatives as required.
- Ensure that all GDP activities are adequately covered by SOPs or appropriate documentation.
- Be involved in the maintenance of the Deciphera NL Quality Management System to ensure medicinal product requirements are met in all markets.
- Handle complaints, deviations, CAPAs, change control, support recalls, destructions, and archiving according to the Deciphera NL Quality Management System and local/global written procedures.
- Execute internal audits for GxP compliance and audits of Contract Manufacturing Organizations (CMOs) and other relevant suppliers.
- Be involved in resolving complaints, deviations, investigation, Out of Specifications (OOS), CAPAs, and change controls related to medicinal products.
- Perform regulatory reporting and product withdrawal/recall for the EU Market.
- Review temperature excursions and initiate appropriate actions.
- Approve or reject returned product back to saleable stock.
- Support establishment and maintenance of quality agreements with customers and suppliers.
- Ensure product quality reviews are executed.
- Issue QP Declarations for sites that are certified to meet GMP requirements.
- Participate in risk assessment, decision-making, communication, and risk reducing action related to defective product.
- Execute batch disposition as per GMP guidelines.
Qualifications:
- Qualification requirements as laid down in the Directive 2001/83/EC and the following directives.
- Either a registered EU QP or eligible as an EU QP rendering to.
- Meet the education minimum requirements as per article 49 sub 2 of directive 2001/83.
- Diploma, certificate, or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology.
- Practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products.
What We Offer:
- Comprehensive benefits package including non-accrual paid time off, summer vacation bonus, global company-wide summer and winter shutdowns, annual lifestyle allowance, monthly cell phone stipend, internal rewards and recognition program, medical, dental, and vision insurance, 401(k) retirement plan with company match, life and supplemental life insurance for family, short and long-term disability insurance, health savings account with company contribution, flexible spending account for either health care and/or dependent care, family planning benefit, and generous parental leave.
We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune's Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here.
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