Quality Assurance & Compliance Manager Менеджер по обеспечению и контролю качестваВакансия в архиве

Уровень зарплаты
з/п не указана
Город
Санкт-Петербург
Требуемый опыт работы
3–6 лет

National BioService LLC, the first in Russia commercial research biobank and bioservice, is looking for manager for Quality Assurance & Compliance Department who will contribute to the achievement of company’s objectives by providing professional support in the development and maintenance of NBS Quality Management System (QMS) as well as the interactions with Ethics bodies at partner clinical sites.

General Responsibilities:

  • Ongoing collaboration with company’s management on various process/procedure improvement matters; suggestion and implementation improvement to current systems and procedures;
  • Detail-oriented approach in reviewing company’s documentation;
  • Identification and resolution of quality issues and application of in-depth knowledge of relevant legislation;
  • In case of quality issues - investigation/audit lead and reporting;
  • Completion of all necessary forms and deviation register in accordance to company’ SOPs;
  • Client/key account communication on various matters related to biospecimen/clinical data quality issues, QC findings, etc.
  • SOPs/Training Materials creation and ongoing maintenance.
  • Engaging with clinical sites at the level of site leadership and administration and contribute to establishing transparent ethical contractual relationships facilitating future collaborative projects.
  • Management of Ethical Committees (IRB) applications and approvals for ongoing and future projects.
  • Ongoing management of relationships with clinical sites and IRBs; identification of issues arising and means of addressing them.
  • Day-by-day basis communication with the clients in the areas of QC and Compliance, Auditing and Certification.
  • Management and control of Informed Consent process at medical sites.
  • Implementation of NBS policies, Federal and International requirements, ethical processes and procedures to ensure compliant execution of projects.

Specific responsibilities:

  • Guides learning and provides coaching to Project management/Site management staff.
  • Prepares detailed internal reports (per request).

Successful candidate should have:

  • Degree in Medicine or Life Sciences. Medical or pharmaceutical background would be advantages.
  • Strong project management and communication skills.
  • Demonstrated ability to influence, communicate and build relationships with new partners and clients.
  • High level of commercial awareness.
  • Upper-intermediate level of English (at least reading and writing).
  • International professional experience will be a plus.
  • Professional background in oncology will be a plus also.

We offer the following:

  • Creative work in an exponentially growing company.
  • Challenging tasks and projects.
  • Competitive salary.
  • Career prospects directly related to your performance and achievements.
  • Friendly Management Team.
  • Full-time employment. Saint-Petersburg.

Interested candidates are asked to submit their CV (in English) and a short statement of interest and related experience.

Ключевые навыки

Английский языкMS ExcelMS WordКоммуникабельностьРабота в командеДеловая перепискаБиомедицинская этикаУправление качествомПисьменный перевод

Тип занятости

Полная занятость, полный день

Адрес

Санкт-Петербург, Литовская улица, 17А
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