Job Code: USRA02
Position: Quality Assurance (Director/Senior Director)
Department: Regulatory Affairs
Reports to: VP, Regulatory Affairs
Location: Remote – West Coast based
Connect Biopharma (Nasdaq: CNTB) is a global, clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research. With operations and expertise in China, the United States and Australia and clinical development activities in those geographies as well as Europe, Connect Biopharma is building a rich pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology.
Director/Sr. Director, Quality Assurance will play a critical role in setting the strategic direction of the Quality Management System and provide key guidance and direction for the implementation of that strategy across the full product development lifecycle. This key role is responsible for ensuring independent Quality oversight and conformance with established GXPs in support of clinical conduct and cGMP manufacturing for global trials and future commercial products, including direct interaction with internal partners, global vendors, health authorities, and consultants. This is a hands-on position where the successful candidate works collaboratively as a business partner to ensure alignment on priorities and incorporates a science-based risk management approach to actions and deliverables.
- Provide leadership and accountability for the Quality Assurance function across global programs; collaborate within the organization to establish clear and seamless Quality Systems and processes that reflect the global nature of the programs.
- Lead the US Quality Systems team and establish goals, priorities, success criteria, and career development plans.
- Responsible for US Quality Assurance, Document Control, and GXP Compliance functions (including training program) in support of compliance across the company.
- Apply phase appropriate GXPs for drug supply, manufacturing, and testing; proactively ensure compliance with all relevant regulations and
- Interpret and provide advice to teams regarding Quality guidelines (ICH, FDA, EMA), GXP regulations, corporate standards, and operating procedures.
- Provide Quality oversight to ensure product is manufactured, tested, stored and distributed according to cGMPs and other applicable regulations.
- Work collaboratively with manufacturing and supply chain counterparts to facilitate timely and effective resolution of process deviations, investigations, CAPAs, and batch record reviews.
- Interact with external manufacturing partners and Qualified Persons to ensure timely release of products.
- Perform and/or provide oversight for vendor audits and qualifications (GMP, GCP, GLP); manage audit schedule and develop plans for requalification.
- Negotiate and approve Quality Agreements, QP Agreements, and related documents.
- Contribute to the oversight, development, and maintenance of controlled documents (Policies, SOPs, Forms, etc.) for all global functions to assure consistency and compliance.
- Manage and adhere to functional area budget, including the identification and allocation of key expenditures and resource needs.
- Establish Inspection Readiness activities and metrics as well as serve as a key inspection host in addition to being the primary point of contact for Quality Systems during audits and inspections.
- Support/review Regulatory filings as needed.
- Minimum of a BA/BS is required, an advanced degree is preferred.
Qualifications and Requirements
- The ideal candidate will possess at least 12 years of experience in Quality, Quality Assurance and/or Quality Compliance within the pharmaceutical and/or biotech industry including at least 8 years of experience in management and/or leadership roles.
- Thorough understanding of quality and regulatory requirements and processes for drug development, conduct of clinical trials, and oversight of pharmaceutical manufacturing and supply chain throughout the lifecycle is required.
- Clear understanding of early and late phase Quality systems/processes with expertise and hands-on knowledge of GMPs and GLPs required; knowledge of PV and GCPs is
- Experience with development of both small and large molecules required, late-stage and commercial experience preferred.
- Experience in a virtual company overseeing Contract Manufacturing Organizations and Contract Testing Laboratories is key
- Ability to collaborate in a multinational environment to achieve shared goals and objectives; prior experience building Quality functions within an emerging global company is also an advantage.
- Experience in combination device products (PFS, autoinjector) is a plus
- Strong critical thinking, problem solving, influencing, and communication skills
- Ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary global team is extremely important.
- Excellent organizational, written, and verbal communications
- Proficient with MS Office applications required; experience with document management systems is a plus; previous experience with selection and deployment of a controlled document system is an advantage.