Quality Assurance Senior Manager

Company Description

Deciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.

Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK® (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.

See here for more details on our portfolio.

Job Description

The Role:

The Quality Assurance Senior Manager / Qualified Person (QP) has direct collaboration and partnership with all associates for implementation of the Deciphera Quality Management System in the EU, Switzerland and UK to achieve a high level of quality and compliance. As a Quality Assurance Senior Manager / Qualified Person (QP), you are responsible with Coordination of the Quality Assurance activities within the local organization, in order to ensure that all aspects related to its operational activities are in accordance with the legal regulations GDP and GMP (GxP) and with the Procedures and Quality Management System within Deciphera Pharmaceuticals (Netherlands) B.V. (Deciphera NL).

As a QP you will be responsible for the release or rejection of batches of medicinal product and oversight of quality for Drug Substance and Drug Product and Finished Drug Product in accordance with Article 51 of Directive 2001/83/EC and the requirements as laid down in the EU GMP requirements. The QP also plays a key role in the creation and maintenance of the Deciphera NL Quality Management System (QMS).

This position will report to the Head of Quality Assurance International.

What You’ll Do:

• To act as the primary contact at the Deciphera NL for Quality Assurance enquiries as appropriate and to support Deciphera globally as required and directed by the Head of QA-International.
• To ensure that all GDP activities are adequately covered by SOPs or appropriate documentation. Ensuring that all SOPs are aligned with corporate expectations and regulatory guidance's.
• Be involved in maintenance of the Deciphera NL QMS to ensure medicinal product requirements are met in all markets where Deciphera is active.
• Handling 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.
• Execute and/or support audits of Contract Manufacturing Organizations (CMOs) and other relevant suppliers to ensure their quality systems meet the requirements and to mitigate the risks from non-compliance-patient safety and regulatory non-compliance that may be found during inspections.
• Be involved in resolving complaints, deviations, investigation, Out of Specifications (OOS), CAPAs and change controls related to medicinal products of Deciphera.
• 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. For products imported from outside the EU or EEA, ensure testing within the EU/EEA to the requirements of the Marketing Authorization and any other tests to assure quality of the products.
• Support hosting regulatory inspections and involved in communications with the inspectors at Deciphera NL or at the manufacturers for the Deciphera products.
• As the Qualified Person you will be responsible for ensuring all medicinal products (from key raw materials to final packaged and labelled drug product) are produced at our GMP compliant Contract Manufacturing Organizations (CMOs) and Contract Service Providers (CSPs) and they are released in accordance with relevant requirements such as the European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use), Product Marketing Authorization(s) and customer specific requirements. The successful candidate will release product and distribute product within the European Union (EU) and surrounding countries (i.e., Switzerland and the United Kingdom).
• Perform Duty of care check for Deciphera drugs products as the QP registered in our GMP License.

Qualifications

What You’ll Bring:

• Qualification requirements as laid down in the Directive 2001/83/EC and the following directives:
  • EU Directive 2003/94/EC (GMP for medicinal products for human use)
  • The Rules Governing Medicinal Product in the European Community, Volume 4: Medicinal products for human and veterinary use: Good Manufacturing Practices
• 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.

Additional Information

What Deciphera will Bring:

Deciphera offers a comprehensive benefits package that includes but is not limited to the following:

• Non-accrual paid time off
• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• An 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
• Generous parental leave
• [if applicable] Car allowance

We offer an outstanding culture and opportunity for personal and professional growth guided by our “PATHS” Core Values and how we work together. 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.