Job Description
Director, Quality Assurance (Biologics, Development & External) Dublin
Our client is a highly successful global pharmaceutical manufacturer.
The Director, Quality Assurance (Biologics, Development & External) will provide Quality oversight for the company’s Biologics program for Drug Substance and Drug Product clinical and commercial, reporting to the Senior Director, Development & External Quality.
The Development & External Quality function represents the quality organization in the day to day support and oversight of technical transfer, validation, GMP production and operations at contract manufacturing and packaging including storage and distribution for all clinical and commercial products. In addition, the Development & External Quality function is also responsible for:
- The Vendor Qualification program
- Design Control for Drug — Device Combination Products, including PMSR
- QA oversight and support of GMP Phase 1 production for both small and large molecule drug substance at the company’s US facility
- QA support and oversight for Analytical Development (Global)
Job Spec:
- Maintain, manage, and enhance quality systems for Biologics Program to ensure they conform to company quality practices and international regulatory compliance requirements
- Ensure that cGMPs are applied to meet commercial and clinical phase appropriate requirements of US/EU and OUS
- Assure compliance to company Quality Systems and regulatory requirements for the manufacture of clinical trial supplies through all phases of development and commercial manufacture
- Provide expertise and guidance in interpreting existing and emerging governmental regulations, agency guidelines and internal policies to assure compliance
- Collaborate with cross-functional teams to provide Quality leadership for Biologic Drug Substance and Drug Product manufacturing
- Provide support to the Senior Director Development & External QA and act as designee where required, including CMC support /representation Review and approval of regulatory
- Lead Quality oversight for Biologics CMOs and escalates quality and compliance issues to the Senior Leadership Teams at company sites and CMOs
- Manage team members which may be remote /offsite to provide QA representation, guidance, leadership, and direction to CMO’s, Process Development Analytical Development and External Operations teams for both Biologics Drug Substance and Drug Product clinical and commercial
- Support team members who will interface with contract manufacturing organizations, oversight responsibilities include review of batch documentation, deviations, investigations, etc. up to and including product release
- Provide technical expertise for product quality decisions and project team decisions
- Identify and evaluate fundamental quality, technical and product development issues and provide leadership, strategic input, guidance and direction for functional areas of the business and partnerships
- Leads and supports investigations associated with major deviations
- Management of quality metrics reporting, non-conformance, change control, and CAPA support
- Partners with internal stakeholders, to enhance the GMP compliance profile by ensuring the timely closure of investigations and implementation of appropriate corrective actions
- Management of quality metrics reporting, non-conformance, change control, and CAPA support
- Ensures that all trends are evaluated, that root causes are identified, and corrective actions are implemented
- Authors, reviews and / or approves internal quality documents (SOPs, deviations, CAPAs, change controls, etc.) and external regulatory agency documents
- Evaluates proposed process changes and improvements. Ensures proposed process changes are consistent with applicable regulatory guidelines and assures changes that affect a regulatory submission or require communication to regulatory authorities are appropriately conveyed.
- Provide QA oversight for regulatory submission for Biologic products
- Provide SME input for Supplier Quality audits
- Provides QA oversight of technology transfer for Biologics products
- Provides input into negotiation of quality agreements with Biologic contract organizations.
Person Spec
- Bachelor degree in Biologics, or related sciences; Master degree preferred
- QP Qualified considered an advantage
- Advanced knowledge of relevant regulations and regulatory guidance including US /EU and OUS required to act as a resource for colleagues
- Demonstrated strength in management, written and oral communication, leadership, and project management skills
- Ability to create and cultivate working relationships and networks across the organization, building agreements that lead to mutually beneficial outcomes
- Ability to work in a fast-paced environment with aggressive project timelines
- Able to direct, motivate, support, and develop team members who are fully engaged in pursuing organizational goals and their individual career aspirations
- Able to broadly apply GMP principals to quality assurance issues, systems and goals
- Ability to support regulatory submissions from early stage to commercial launch
- Ability to manage budgets and react appropriately
- Root Cause Analysis Training
- Excellent problem solving and decision-making abilities
- Self -motivating individual comfortable working with detailed information and data
- Excellent organizational skills
- Excellent verbal/written communication and interpersonal skills
- Strong presentation skills
- Minimum of +12 years of related progressive experience in pharmaceutical Quality Assurance to include a minimum of 5 years of people management/direct leadership experience
- Advanced knowledge and understanding of Biologics Drug Substance and Drug Product manufacturing process in GMP environments and analytical testing
- Advanced knowledge of manufacturing and testing clinical and commercial Biologic Drug Substance and Drug Product
- Advanced, thorough understanding and working knowledge of current Biologic related regulatory requirements and expectations (US, OUS, International Conference on Harmonization (ICH) and European) with the ability to determine phase appropriate requirements.
- Experience in implementation and administration of quality systems to support production of clinical trial materials for Biologic Drug Substance and Drug Product manufacturing, technical transfer, analytical method development, validation and transfer
- Experience in facilitating and supporting regulatory audits and follow up (FDA, EMEA, PMDA, etc.) in support of pre-approval and general inspections
- Experience with Quality Oversight Experience of Contract Manufacturing Organizations
- Direct experience participating and supporting regulatory inspections and submissions
- Ability to travel based on business needs up to 50%, international and domestic travel.