Senior Director Quality Assurance - Biotech
Proclinical is currently recruiting for a Senior Director of Quality Assurance with a very exciting biotechnology company located in Boston, MA. Successful candidate will be responsible for the continued development, realization and execution of cost effective, risk-based, and compliant quality assurance and compliance programs and systems in support of the company infrastructure as well as external collaborations in order to fully support drug development activities.
- Collaborating with internal and external stakeholders and partners to enable and ensure appropriate implementation of the quality assurance requirements of Drug cGMPs, GCPs, GLPs and associated industry guidelines as appropriate.
- Creating and maintaining a culture of collaboration and alignment among critical functions to ensure strategic objectives are met across all aspects of our operations and quality programs, processes and projects.
- Developing key quality processes, metrics and indicators to measure, trend manage and improve key quality attributes of our virtual supply network, as well as strategies and tactics to communicate progress and issue resolution to appropriate internal/external stakeholders.
- Ensuring the company is in a constant state of inspection readiness across all functions through continuous education, training and internal audits.
- Manages and develops a group of Quality professionals who are collectively responsible for carrying out the QA responsibilities, including:
- Assuring that the appropriate suite of SOPs in place and optimally maintained to support the critical drug development activities as well as our vendor relationships with our external CRO or CMOs.
- Providing consultation and direction on quality assurance and GCP/GMP/GLP compliance to supported functions
- Ensuring the review and audit of internal department processes for compliance with applicable GCP, GMP and/or GLP regulations or guidance's.
- Assures the planning and conduct of periodic compliance training on GLP, GMP and GCP regulations.
- Ensuring a robust and risk-based audit program is successfully realized throughout our vendor network.
- Managing and coordinating all associated GxP regulatory inspections.
- Facilitating all appropriate authoring and implementation of Quality related SOPs as well as review of functional SOPs.
- Negotiating. Developing and executing appropriate development and management of value-added quality agreements with CMOs, CROs, partners and suppliers
Skills and Requirements:
- We are seeking a highly experienced and motivated individual that is happy to roll their sleeves up in a highly visible role within the organization.
- This individual must have excellent interpersonal and communication skills, including the ability to influence behaviors and negotiate and resolve challenges with diplomacy.
- Expert knowledge and practical experience of GCP and GMP.
- Expertise in supporting FDA pre-approval inspections.
- Experience in representing QA on cross functional development teams .
- Experience in supporting global clinical studies.
- Excellent working knowledge with the practical implementation of FDA and EMA regulations and guidelines in GxP environments.
- Minimum of 15 years' quality assurance experience in mainstream pharmaceutical/biotechnology industries.
- Continuous development into current regulations, guidelines and industry standards.
- Working knowledge of GVP and GLP preferred.
- Experience in working in a company transitioning from an R&D to Commercial organization.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Will Hitchcock at (+44) 203-078-9554 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.