layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Senior Manager, GMP Investigational Quality at Syndax Pharmaceuticals | LAYIQ

Support GMP Quality oversight for early phase investigational programs, including review and approval of master batch records, executed batch records, certificates of analysis, specifications, method qualification protocols/reports, and supporting source documentation for drug substance, drug product, and clinical finished goods.
Support clinical finished goods release activities, including review of packaging and labeling records, label proofs, expiry/retest information, temperature excursion documentation, and product release, including QP release support.
Effectively interact with external contract manufacturers, CDMOs, contract laboratories, packaging and labeling vendors, and internal cross-functional partners to support manufacturing, testing, packaging, labeling, storage, and distribution of materials for Syndax development programs.
Manage and address associated deviations, investigations, CAPAs, change controls, OOS/OOT events, product complaints, and other quality events with a focus on product impact, patient safety, data integrity, and clinical supply continuity.
Lead investigations into quality issues; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions to closure and confirm effectiveness.
Partner with CMC, Analytical Development, Supply Chain, Clinical Operations, Regulatory Affairs, and external partners to identify GMP risks, resolve quality issues, and support timely execution of early phase clinical supply activities.
Identify and mitigate GMP compliance risks, quality system gaps, and process improvement opportunities related to early development, investigational material release, and clinical finished goods operations.
Work closely with the Quality Assurance team to ensure alignment with Syndax Quality Systems, including consistent application of procedures, documentation standards, and risk-based decision making.
Author, review, and/or approve GMP quality documents, including deviations, change controls, CAPAs, SOPs, and quality agreements, as applicable.
Maintain clear communication of quality risks, open issues, release readiness, and clinical supply support activities.
Operate independently with guidance from manager and senior staff; demonstrate sound judgment, ownership, and the ability to articulate complex GMP issues clearly verbally and in writing.
Desired Experience/Education and Personal Attributes: BS degree in a scientific field required.
Minimum of 5 years of experience in the pharmaceutical or biotechnology industry, with GMP Quality experience supporting contract manufacturing organizations and clinical-stage development programs.
Experience supporting early phase clinical programs, including GMP oversight of drug substance, drug product, and/or clinical finished goods manufacturing, packaging, labeling, storage, and distribution activities.
Experience reviewing and approving master batch records, executed batch records, clinical packaging and labeling records, certificates of analysis, method qualification protocols/reports, and other GMP documentation.
Experience supporting clinical labeling and packaging activities, clinical finished goods release, expiry/retest dating, temperature excursion assessment, and QP release activities.
Experience managing or supporting deviations, investigations, CAPAs, change controls, OOS/OOT events, complaints, and product impact assessments in a GMP environment.
Must have experience working in cross-functional teams, including CMC, Analytical Development, Supply Chain, Clinical Operations, Regulatory Affairs, and external vendors or suppliers.
Strong technical writing skills and ability to translate complex GMP issues into clear, inspection-ready documentation.
Excellent communication skills with the ability to collaborate effectively across internal teams and external partners.
Strong judgment, project management, and decision-making skills; able to manage multiple projects, competing priorities, and demanding clinical supply timelines.
Ability to rapidly synthesize complex issues, identify compliance and patient safety risks, and apply pragmatic, risk-based solutions.
Self-motivated, independent, and comfortable operating in a fast-paced, fully outsourced or hybrid outsourced manufacturing environment.
Location
: Syndax’s corporate office is in New York, NY.

Senior Manager, GMP Investigational Quality

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