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Quality Systems Manager

4 months ago

Cambridge Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Lexington, MA.

Culture is key and all Bicycle employees actively embrace and role model our company values:

  • Weare Adventurous .We believe it’sthewaytodeliverextraordinaryresultsforourpatients.
  • Weare DedicatedtoourMission .Youcan’tchangetheworldifyoudon’thavedetermination.
  • Weare OneTeam .Weonlysucceedwhenweworktogether.

Job Description

We have a new opportunity within our CMC Quality function for a collaborative and highly skilled Quality Systems Manager.

Reporting to the Senior Director, CMC Quality, you will support both the UK and US sites to maintain robust and phase-appropriate GxP systems, lead on system changes, improvements and new system implementation, and ensure the company's GxP systems are maintained and validated in line with regulatory requirements and industry trends.

Key responsibilities

  • Provision of technical expertise and leadership in improving and maintaining Bicycle’s Quality Systems and GxP software.
  • Lead on projects to implement system integrations and improvements as GxP subject matter expert.
  • Partners with IT GXP SME
  • Work with IT to perform period review of GxP computerised systems.
  • Subject Matter Expert for GxP Computer System Validation and data integrity, working in partnership with Bicycle IT functions and functional stakeholders to facilitate user specification design, write validation documents including test scripts.
  • Perform validation activities alongside IT, and join cross functional teams to perform UAT.
  • Oversee the electronic Quality Management System, including routine GxP administration and management of Quality procedures/policies.
  • Participate in the creation, review, revision and maintenance of Standard Operating Procedures (SOPs) and controlled documents for GxP activities.
  • Work with functional leaders and Quality to set-up, maintain and improve automated generation of metrics from the Quality Systems to inform the Business of the health of Bicycles Pharmaceutical Quality System (PQS). Ownership of QMS related to Quality KPIs for Quality Management Review and design and maintenance of QTLs and associated thresholds to support risk assessment and process improvement initiatives.
  • Ensure that Bicycle Quality Systems are always inspection ready, and where gaps are identified ensure that action plans are in place to return to a compliant state.
  • Manage the self-inspection and internal audit program for GxP Quality Systems and data integrity.
  • Provide GxP IT training to IT staff.
  • Qualify GxP software providers where necessary per Bicycle Supplier Qualification procedure (this may include some audit travel where applicable).

Qualifications

  • ISPE GAMP5 trained
  • Experienced in implementing and managing an electronic Quality Management System
  • Strong understanding of ICG GCP and GLP
  • Experienced in implementing an inventory management system
  • Strong background in GxP Quality and Compliance with a strong understanding of both FDA and EU regulations, in both R&D and CMC development settings
  • Highly collaborative, strong relationship building skills with a high level of integrity.
  • First class communication and influencing skills with the ability to manage multiple stakeholders.
  • Resilient and able to work effectively in a demanding and fast-paced environment. 

Additional Information

  • State-of-the-art campus environmentwith on campus restaurant and Montessori nursery
  • Flexible working environment
  • Competitive reward including annual company bonus
  • Employee recognition schemes
  • 28 days annual leave in addition to bank holidays+ option to buy up to 5 additional days annually
  • Employer contribution to pension (employee does not have to contribute)
  • Life assurance cover 4x basic salary
  • Private Medical Insurance, including optical and dental cover.
  • Group income protection
  • Employee assistance program
  • Health Cash Plan
  • Access to company subsidized gym membership.
  • Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
  • Cycle to work scheme

Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.