QA Manager

Position Summary

QA Manager will support managing quality assurance lot release activities for the disposition of drug substance (DS), drug product (DP) and finished drug product manufactured at Eidos’ contract manufacturing organizations (CMOs). This individual will support as a quality liaison with assigned CMOs, including management of the review and approval of manufacturing batch records, certificates of analysis and the issuance of certificates of compliance. The Eidos, QA Manager will ensure that the CMO SOPs and batch records are in compliance with cGMPs. This position will serve as the primary technical quality reviewer and approver for deviations, change records and CAPAs generated from or pertaining to our CMOs. This individual will interact closely with CMOs and internal stakeholders such as quality control, manufacturing, regulatory affairs and supply chain.

Essential Duties and Responsibilities

  • Perform quality review and provide guidance of quality events (deviations, change requests, supplier notifications, etc.) as documented by contract manufacturers and manufacturing operations departments
  • Represent QA on project teams responsible for drug substance, drug product and finished drug product manufacturing and testing
  • Review drug substance, drug product master and manufacturing batch records from CMOs, including related documents such as specifications, analytical and microbiological methods, stability study protocols and label proofs
  • Manage lot release activities and communication of lot release schedules to key stakeholders
  • Communicate manufacturing deficiencies/non-conformances to management and work with vendors to ensure timely resolution
  • Participate in the GMP vendor qualification and audit programs and monitor CMO performance
  • Review process and method validation protocols and reports
  • Review analytical test results to ensure compliance with approved specifications
  • Assist in updating CMC sections of regulatory and quality documents (INDs, IMPDs and Annual Reports)
  • Participate in vendor audit
  • Participate in hosting regulatory inspections
  • Participate in internal and external project team meetings
  • Write and review SOPs and quality assurance procedures
  • Other duties as assigned

Qualifications

  • Bachelor’s degree or higher in science, mathematics or engineering required
  • Minimum 10 years of experience in a quality assurance role in the pharmaceutical industry required
  • Must have previous experience with managing pharmaceutical CMOs both international and domestic
  • Extensive knowledge of US and European drug substance and drug product GMP requirements and associated guidelines
  • Experience in the identification and resolution of GMP quality and compliance issues
  • Comfortable working in a virtual bio-pharmaceutical organization with multiple global third-party providers
  • Strong planning and time management skills with ability to prioritize workload
  • Ready to embrace Eidos’s core values and diverse corporate culture
  • Up to 15% of domestic and international travel required

 

Director, Project Management

Position Summary:

The Director, Project Management is accountable for establishing and maintaining an integrated Project Plan to cover all aspects of the AG10 Development Program at Eidos. The successful candidate will track and provide logistical support of cross-functional plans and activities across Clinical Operations, Clinical Research, and Regulatory Affairs, integrating parallel activities within the Nonclinical realm (Toxicology, CMC, Drug Supply) as they need to be coordinated with the clinical and regulatory activities. In this capacity the Director, Project Management will primarily interact with and support the senior staff within the Clinical and Regulatory functions (Chief Medical Officer and heads of Clinical Development, Clinical Operations, and Regulatory Affairs) and Nonclinical Project Management to ensure that cross-functional planning and execution are integrated, that risks and mitigation of those risks are identified, and any gaps in resource needs proactively identified and addressed. The successful candidate must have the ability to lead and motivate people, encourage teamwork, an ability to communicate effectively with senior management and external partners, and a clear vision of what defines a successful project management process for all stakeholders.

Essential Job Functions:

  • Establish and maintain the integrated AG10 Development Project Plan
  • Plan Project Team Meeting agendas with enough advance time to accommodate the preparation and circulation of pre-reads and/or presentations for major topics driving project decisions; prepare and circulate minutes to focus on immediate assignments and follow-up of prior assignments; serve as meeting host and effectively manage time allocation to specific topics
  • Oversee ongoing development and maintenance of integrated cross-functional project plans as they influence the evolving Target Product Profile to enable accurate financial analysis and planning
  • Oversee all program management activities including planning, reporting, global risk assessment and mitigation, and lessons-learned
  • Reporting and presentation of program information to the Executive Team, functional heads, and other key stakeholders
  • Contribute to long-range planning and budgetary planning at the program level
  • Facilitate decision-making, collaboration, and problem-solving with people at all levels of the organization to accomplish shared program goals
  • Effectively manage multiple projects and responsibilities concurrently
  • Analyze risk and implement risk management strategies.
  • Establish contingency plans and identify trigger events and responsibility for initiating corrective action.
  • Track actual performance against the plan and propose adjustments consistent with plan objectives.
  • Keep all stakeholders informed of progress and issues.
  • Responsible for ensuring adherence to agreed-upon team goals and deliverables. Prepare agenda and keep track of action items of the Project Team meeting.

Additional Responsibilities and Duties:

  • This position will require some (<20%) amount of travel as appropriate.

Education and Experience:

  • Bachelor’s Degree in a scientific discipline, advanced degree is a plus: PhD, PharmD or equivalent preferred; MBA or certification in project management also a plus.
  • A minimum of 10 years of biotech/pharma industry project management experience including 5+ years leading a cross functional core team and 3+ years in Rare Disease highly desired.
  • Demonstrated understanding of clinical and nonclinical drug development is required.
  • Experience in a functional supervisory role

Skills and Abilities:

  • Solid project management and organizational skills
  • Strong leadership skills
  • Demonstrated ability to establish and maintain effective communications internally and with external partners
  • Outstanding influencing skills up, down and across the organization including executive/senior management
  • Track record of delivering in a fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful and efficient
  • Familiarity with risk management strategies
  • Ability to work strategically and independently with internal and external groups on multiple projects
  • Expert planning and tracking skills, able to see big picture, well-organized, focused on results, capable of managing multiple projects, excellent time management with respect to priorities and self-management