Compliance Manager
Operating at a professional level, working independently on projects with limited advice and support. May line manage administrative or support staff.
The Global Cell Bank is critical for delivering cellular models to enable our drug discovery projects. We are seeking a highly motivated and independent individual with background experience in cell biology to join our team in Warsaw. As compliance manager for cell lines coordinatoryou’llbe responsible for keeping track, renewing and establishing new licenses for cell lines that are used across AstraZeneca R&D. You'llbe responsible for assessing licensing paperwork and communicating with scientist about new licenses and renewal processes. Internally you’ll work with procurement and Business development to liaise with vendors in drafting contracts on behalf of scientist.
Responsibilities:
Work with the business and procurement to put licenses/contracts in place.
Responsible for the compliance of immortalised cell lines within AstraZeneca R&D in accordance with the relevant Policies and Standards.
Responsible for reviewing applicable local regulatory/legal requirements for appropriate use and/or transfer of cell lines.
Responsible for tracking and ensuring payments are made on time as required by applicable licenses and/or applicable documentation.
Responsible for annual cell line usage reviews aligned to vendor requirements.
Ensure that required licenses/contracts and permits are in place prior to purchase or transfer from/to internal/external sources and followed up appropriately.
Responsible for raising and tracking Purchase Orders.
Ensure compliance of the global cell line data base (Limfinity).
Ensure alignment of all cell banks to the global process as outlined in the Global Standard.
Requirements:
Essential
Degree level or equivalent qualifications
Excellent communications skills (verbal and written) with the ability to present information in a clear and concise format to all levels within the organization
Ability to work effectively with colleagues/collaborators from a diverse set of backgrounds, levels of seniority, and territories
Strong influencing and negotiation skills
Good understanding of governance including cell line licenses, ethical and biosafety requirements for working/sharing cell lines.
An understanding of the drug discovery process
Excellent analytical, written and oral communications skills
Strong ability to work independently
High ethical standards, trustworthy, operating with absolute discretion
Desirable
Experience in negotiating commercial terms and contract clauses
Experience in and knowledge of pharmaceutical industry
Ability to manage negotiations, expectations, and solutions across complex groups
Excellent attention to detail.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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