Director, Quality Control

🕒 April 28

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🔴 Lead

👔 Director

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BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $450M Post-IPO Debt - BioCryst Pharmaceuticals on 2023-04

Biotechnology • Pharmaceuticals

BioCryst Pharmaceuticals, Inc. is a global biotechnology company focused on the discovery, development, and commercialization of novel oral small-molecule and protein therapeutics for rare diseases, notably hereditary angioedema (HAE). Founded in 1986, BioCryst uses structure-guided drug design, medicinal chemistry, and advanced technologies to develop first-in-class or best-in-class medicines, and works closely with patients, advocacy groups, and global partners to bring treatments to market.

📋 Description

• Provide quality and technical oversight and governance for all QC activities including raw material, in‑process, release, stability, and special testing for drug substance, drug product, and combination devices. • Ensure QC laboratories/operations operate in compliance with applicable regulations and internal standards. • Act as the primary Quality escalation point for critical QC‑related quality and compliance issues. • Provide quality oversight and approval of Laboratory Investigations, (including OOS, OOT, atypical results, deviations, and data integrity events), ensuring investigations are scientifically sound, risk‑based, appropriately escalated, trended for systemic issues, and supported by effective CAPAs through closure. • Trend QC events and ensure systemic issues are identified and addressed. • Establish and maintain lifecycle management for reference standards and critical reagents, partnering with Analytical Development to define qualification strategies, potency assignment and requalification approaches, while ensuring consistent implementation across internal QC labs and external testing partners. • Provide Quality oversight and lifecycle management of the global stability program, including protocol design input and approval, execution oversight, data review and interpretation, trend analysis, and reporting while ensuring that stability studies support regulatory filings, shelf‑life assignments, and ongoing product verification. • Provide oversight for annual product quality reviews associated with QC data (e.g. OOS/OOT trends, stability data, CoAs/QC release testing). • Ensure robust processes for CoA generation, review, and approval processes for clinical and commercial materials ensuring analytical data integrity, specification compliance, and alignment with regulatory filings. • Oversee specification management, including establishment, review, approval, and lifecycle maintenance for drug substance, drug product, and combination devices in collaboration with Pharmaceutical Sciences. • Ensure alignment on scientific justification and regulatory rationale, while verifying specifications are scientifically justified, phase‑appropriate, and aligned with regulatory commitments. • Partner with Regulatory Affairs to support specification‑related regulatory submissions and variations. • 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. • Ensure methods are robust, controlled and compliant across external testing sites. • Lead and/or support Quality Assurance (QA) audits and regulatory inspections of QC laboratories, serving as a Quality SME. • Confirm inspection observations, audit findings and regulatory commitments are effectively addressed and sustained. • Ensure QC‑related processes are appropriately defined within the Quality Management System (QMS), including SOPs, training, change control, and risk management. • Drive continuous improvement initiatives across QC processes, analytical efficiency, and compliance maturity. • Contribute QC metrics, trends, and risk assessments to Quality Management Review (QMR) and Quality Council 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.

🎯 Requirements

• Advanced degree in Chemistry, Pharmaceutical Sciences, Biology, Engineering, or related scientific discipline (MS/PhD preferred). • Minimum twelve (12) years of pharmaceutical/biotechnology quality experience, including significant experience in QC, QA oversight of QC, and/or analytical sciences. • Demonstrated experience supporting small molecule, biologics, and/or combination device programs. • Strong working knowledge of FDA, EMA, ICH and EU GMP and global regulatory expectations for laboratory operations. • Proven experience supporting regulatory inspections and managing complex QC‑related compliance issues. • Strong understanding and ability to implement risk management fundamentals/tools. • Experience with statistical analysis of analytical data and method capability with strong scientific and analytical judgment. • Deep understanding of laboratory investigations and data integrity. • Demonstrated ability to apply scientific judgment to analytical data interpretation, method performance issues, and complex laboratory investigations. • Excellent organizational skills and ability to work on multiple projects with competitive timelines is required. • Excellent communication, negotiation, and presentation skills; maintains high ethical standards, and enjoys working with people and information, making decisions, problem solving, making a difference and working in a leadership role. • Demonstrated ability to work effectively in cross functional team environment and independently in a remote work setting, as necessary. • Excellent problem-solving and decision-making skills.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off