Senior Director of Quality Operations
Job Type
Full-time
Description

Arbor is looking for a Senior Director of Quality Operations to play a critical role in working with cutting edge science to develop life-changing therapies for patients. This role will report to the Vice President, Head of CMC and Quality and will be responsible for Quality Operations activities (QA and QC) supporting CMC operations. If you are looking for an entrepreneurial, science-driven, collaborative environment then Arbor is the place for you. Reporting to the Vice President, Head of CMC and Quality, this role will be responsible for Quality Operations within Arbor Biotechnologies and across a network of external vendors used for the development, manufacture, testing of Arbor’s pipeline. The Senior Director of Quality Operations will provide oversight of department activities, technical development of personnel and ensuring the quality of deliverables within the role's purview. The role requires technical proficiency and establishes the strategic alignment of group and department goals, adjusting as necessary through proactive monitoring.


Key Responsibilities:

· Direct the activities of the Quality Operations team (QA &QC), developing, implementing, and maintaining policies and procedures to ensure effectiveness of quality programs, with a continues focus on improvement and efficiency

· Acts as the main point of contact for all Quality matters, internally and externally.

· Maintain an effective Quality Management System (QMS) that aligns with regulatory requirements/expectations.

· Develop and implement Arbor Quality Plan, objectives, and related procedure

· Provide direction to operations personnel during handling and resolution of change control, deviations, non-conformances, CAPAs and product quality risk analysis

· Ensure development and approval of specifications, sampling instructions, test methods and other Quality Control procedures.

· Oversees the negotiation, monitoring, and maintenance of all Quality Agreements with Partners, CMOs, Contract labs, vendors, where applicable.

· Oversees supplier management programs and ensures CMO, vendor and supplier oversight and monitoring performance for continuous improvement.

· Accountable for the execution of all management reviews (QMR)

· Establishes and directs development of Quality Metrics to support process improvement activities.

· Leads Material Review Board discussions, as necessary.

· Ensures the development of appropriate SOPs, ensuring regulatory compliance in conjunction with being fit for purpose operationally.

· Support regulatory submissions aligning with filing strategy; reviews and escalate submissions amendments of notable risk.

· Directs the planning and effective implementation of the internal and external audit program.

· Supports external vendor audits and ensure that audit response commitments are completed in a timely manner.

· Participates in cross-functional projects in Quality expert role.

· Accountable for the management and oversight of the Arbor Biotechnologies’ Vendor Management Process including the approved vendor list.

· Accountable for the risk management program to ensure that the analysis and documentation of risk is incorporated into the decision-making process for activities that have the potential to impact product, process, and systems.


Preferred Qualifications:

· Extensive knowledge and proven leadership managing Quality Assurance, and Quality Control teams

· Master’s degree in Life Science, Computer Science or related field.

· Excellent communication and collaboration skills.

· 15+ years in Quality Systems/Quality Assurance/Quality Control related experience in the life sciences industry.

· Experience with biologics in a biotechnology setting is required, and experience with protein, RNA, cell, and/or viral products is preferred.

· Understanding of FDA/EMA/ICH regulations and experience with GxP guidelines on cell and gene therapy products preferred

· Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.

· Working knowledge of current GxP requirements such as Good Manufacturing Practices (cGMP – 21 CFR Part 210/211), and Electronic Records; Electronic Signatures (21 CFR Part 11).

· Proficiency in the use of Microsoft Office, PowerPoint, electronic quality management systems (i.e., eDMS, eLMS, and eQMS).

· Demonstrated ability to collaborate with both internal and external parties to achieve targeted objectives

· Demonstrated organizational skills to managing multiple projects and priorities.


Our Values:

Our values govern the work we do at Arbor, and we’re hoping that they resonate as strongly with you as they do with us!

  • Astonishingly Connected: The best work happens when we do it together. At Arbor, we believe strong, clear communication is crucial to our success and emboldens collaboration in all of us.
  • Our People are Gems: And we treat each other as such by celebrating our growth and development. We invest in our team and encourage everyone to have both a learners mindset and a willingness to teach others.
  • Remarkably Mighty: You'll be intrigued when you take a closer look at Arbor. We approach our work with integrity and thoughtfulness. We are brave, which leads us to take smart risks and make bold discoveries.
  • Authenticity is Encouraged: From eating cheese puffs with chopsticks, to doing cartwheels on our balance beam, we're all about embracing your true self and showing up as you really are. Our differences make us extraordinary.

About Arbor:

At Arbor, we are discovering, developing and making available to all patients the next-generation of genetic medicines. We are disrupting the field through our proprietary discovery engine to develop a portfolio of differentiated genetic editing and delivery capabilities. We have an unencumbered portfolio of multiple CRISPR based genetic modifiers that can be tailored to correct the underlying pathology of each genetic disease. Our pipeline of genetic medicines will focus on bringing cures to all patients with genetic disease.

We seek highly-motivated individuals with the dedication, integrity, and creative spirit needed to thrive in an innovative company. Working at Arbor offers a unique opportunity that combines the fast pace and growth opportunities of a startup with the intellectual rigor and creativity of academia. Our salaries are competitive, our benefits are generous, and our team is exceptional.

Arbor Biotechnologies is proud to be an inclusive workplace and an Equal Opportunity Employer.