Director, QA for QC

Intellia•Cambridge, MA

1d•Hybrid

About The Position

The Director, QA for QC is responsible for providing strategic and operational quality oversight of Quality Control activities supporting the development, manufacture, testing, release, and lifecycle management of gene editing products. This role provides technical leadership and scientific decision-making for analytical control strategies, method performance, reference standards, specifications, and laboratory investigations, and serves as a recognized technical authority for QC-related matters across the product lifecycle with particular emphasis on building the analytical rigor, data-driven predictability, and organizational maturity required to support successful transition from clinical to commercial manufacturing. A critical focus of this role is establishing and maturing trending and predictive quality capabilities using stability, routine release, and in-process testing data and supporting the maturity of a QC oversight function appropriately scaled for commercial supply. The Director will also serve as a mentor and technical coach to personnel in QA for QC department. The Director ensures QC activities are executed in compliance with global GMP regulations and internal Quality Systems, and serves as the primary Quality authority for QC compliance, analytical control strategy, investigation oversight, stability programs, reference standards, and test method governance. This role partners closely with Analytical Development to ensure effective method design, lifecycle transfer, performance characterization, and alignment of analytical control strategies from early development through commercialization, and partners with QA GMP Operations, Global Technical Operations, Process Development, Regulatory Affairs, and external testing laboratories/CMOs.

Requirements

Prior experience with direct or indirect oversight of employees.
Knowledge of the use and interpretation of FDA and ICH regulatory guidelines and pharmacopeias such as USP/NF, EP, and JP
Knowledge and experience with electronic systems such as EDMS, LIMS, etc.
Prior experience with requirements for stability in the pharmaceutical industry and generation of in-house reference standards is key.
Experience with data analysis software such as JMP, MINITAB, GraphPad Prism, PLA, etc.
Detail oriented and able to manage multiple, competing priorities and have strong verbal and written communication skills and delegation of the tasks within a team.
Technical understanding of analytical techniques, including HPLC/UPLC, CE, compendial, UV, bioassay and gel electrophoresis.
Strong leadership qualities including strategic thinking, innovation, mentoring and collaboration.
Excellent written and verbal communication skills are essential.
Excellent organizational skills and attention to detail.
Strong analytical and problem-solving skills.
10-12 years of relevant industry experience.
Experience in phase appropriate GMP testing, and Lab Operations of cell/gene therapies or biologics
Expertise in qualification, validation, transfer and life cycle management of analytical methods
Experience in Health Authority Inspections, related observations and implementation of CAPAs
Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines with excellent time management and organizational skills
Proven track-record to collaborate effectively in a cross-functional matrix environment and lead with curiosity and influence across functional and organizational lines
Experience with IND or BLA filing of ATMP/biologic products.
Experience with commercial QC activities

Nice To Haves

Advanced degree in Chemistry, Molecular/Cell Biology, Pharmaceutical Sciences, Biotechnology, Engineering, or related scientific discipline (MS/PhD preferred)

Responsibilities

Provide quality and technical oversight and governance for all QC activities, including Drug substance/Drug Products release, stability, and specialized testing for gene editing therapies.
Ensure outsourced testing operations operate in compliance with applicable global regulations (FDA, EMA, ICH) and internal Quality standards appropriate to novel modality products.
Act as the primary Quality escalation point for critical QC-related quality and compliance issues, applying sound risk-based judgment given the evolving regulatory landscape for gene editing therapeutics.
Establish and lead a robust, data-driven trending program leveraging stability, release, and routine testing data to proactively identify shifts in analytical, process, or product performance enabling predictive quality management.
Partner with Analytical Development, Process Development, and Manufacturing Sciences to build statistically sound approaches to specification setting, control limits, and continued process verification (CPV) that support commercial-scale manufacturing.
Champion the use of statistical tools, control charting, and multivariate trend analysis to support early detection of variability and to inform proactive risk mitigation ahead of formal investigations.
Ensure trend outputs are meaningfully integrated into QRM pathways.
Provide quality oversight and approval of External Laboratory Investigations (OOS, OOT, atypical results, deviations, data integrity events), ensuring investigations are scientifically sound, risk-based, appropriately escalated, trended for systemic issues, and supported by effective CAPAs through closure.
Support lifecycle management for reference standards and critical reagents unique to gene editing platforms (e.g., guide RNA/Cas reference materials, vector reference standards), partnering with Analytical Development on qualification strategies, potency assignment, and requalification approaches across internal QC labs and external testing partners.
Support lifecycle management of the stability program, including protocol design input/approval, execution oversight, data review and interpretation, trend analysis, and reporting, ensuring stability data supports regulatory filings, shelf-life assignments, and ongoing commercial product verification.
Oversee specification management for drug substance/drug product, ensuring specifications are scientifically justified, phase-appropriate, and reflect maturing process/analytical understanding as the program advances toward commercialization.
Provide Quality and technical oversight of analytical method validation, verification, lifecycle management, and method transfers in close collaboration with Analytical Development, including review of validation design, acceptance criteria, and method performance trends across novel and platform-specific assays.
Partner with Regulatory Affairs to support specification-related regulatory submissions, variations, and pre-commercial regulatory interactions specific to gene editing product classes.
Lead and/or support QA audits and regulatory inspections of QC laboratories, serving as a Quality SME for gene editing analytical control strategy; ensure inspection observations, audit findings, and regulatory commitments are effectively addressed and sustained.
Serve as a technical mentor and coach to QC and QA personnel whose experience is primarily in early-phase/clinical settings, actively building capability, judgment, and rigor needed for commercial GMP operations.
Drive continuous improvement initiatives across QC processes, analytical efficiency, and compliance maturity, with a focus on right-sizing systems for sustainable commercial operations.
Contribute QC metrics, trends, and risk assessments to Quality Management Review (QMR) and other forums.
Provide functional leadership, mentoring, and development for QA staff supporting QC oversight.
Support selection, qualification, and ongoing oversight of external QC laboratories and CMOs supporting gene editing product testing.
Recruits, interviews, hires, and trains new QA for QC staff.
Oversees the daily workflow of the department.
Provides constructive and timely performance evaluations.
Handles discipline and termination of employees in accordance with company policy.
Manage expectations for specific role designations such as remote and hybrid employees and ensure the expected time on site is being met.
Manages individual employee workloads are commensurate with the job level and distributed such that assignments are completed on time and without delaying the overall timelines/goals impacted by the deliverables.
Mentors employees and set the examples for compliance with current GMP practices applicable to Quality Control.
Support the team maturation with the company transformation into a clinical/commercial organization.