Director, CMC Quality (San Francisco)

Director, CMC Quality (San Francisco)

Company: Aligos Therapeutics

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Founded in 2018 and headquartered in South San Francisco, California, Aligos was founded with the mission to become a leader in the treatment of liver and viral diseases. Our team of respected scientists use their decades of experience to build a cutting-edge pipeline of transformative treatment options that have the potential to change lives. A highly-collaborative, fast-paced work environment where we honor accountability, transparency, and diversity.

Job Overview

The Director, CMC Quality will report to the Executive Director, Quality Assurance and will be responsible for providing Quality oversight and support of cGMP-related CMC activities for Aligos Therapeutics development programs to assure that project timelines and deadlines are met efficiently while ensuring that CMC activities adhere to GxP requirements. This is an exciting opportunity to make an impact in helping to further define and evolve this function at Aligos.

Responsibilities

• Working with Aligos Quality, Regulatory, and CMC team members in developing strategies for Aligos programs to ensure cGMP compliant manufacture of high-quality clinical supplies and potential commercial products across all phases of clinical development.
• Overseeing internal and vendor GMP-related activities from a Quality and Compliance perspective and tracking vendor performance.
• Working with the Quality team to develop and implement Quality programs and policies to ensure compliance with all relevant regulations and promote exacting standards for product quality, study integrity, data integrity, and assurance of patient safety.
• Working with the CMC team in developing Standard Operating Procedures and internal processes for CMC and Quality GMP functions.
• Working with the Head of Quality on the planning and conduct of CDMO audits and CDMO Quality Agreements.
• Identifying potential program level, study-level, and batch-level CMC Quality-related risks and working with colleagues in developing mitigation strategies and communicating risks to relevant parties.
• Managing/participating in all aspects of CMC Quality.
• Review and approval of analytical testing across the supply chain.
• Disposition of materials at each stage of production.
• Assessment of appropriateness and risk of proposed process and analytical changes, deviations, OOSs/OOTs, complaint investigations, and other development data and plans.
• Assessment of stability plans/protocols/data/reports and shelf-life dating.
• Planning and assessment of test method and process validation activities.
• Working with QP teams to facilitate the release/certification of materials for shipment or release in regions outside of the US.
• Promoting the concepts of ALCOA+4, SQUIPS, GxP, and Quality principles throughout Aligos.
• Developing Quality initiatives to direct procedural and process improvements, including assisting the Quality team in developing and maintaining the Aligos electronic Quality Management System.

Qualifications

• BS/MS Degree with 10+ years of relevant progressive quality management experience related to oversight of drug development.
• Demonstrated experience in the biopharmaceutical industry including an ability to operate in a matrixed project team environment which includes all cross-functional aspects of drug development (e.g., nonclinical, CMC, regulatory, clinical, etc.) to achieve quality goals.
• Demonstrated experience of small molecule CMC quality oversight for manufacturing and release of drug substance, drug product, and worldwide clinical supplies through late-stage development.
• Advanced knowledge of GxP Quality principles, concepts, regulations, industry practices and standards, especially as they relate to cGMP-activities.
• Proven track record of ability to build and manage relationships with CDMO partners.
• Experience with computerized systems requirements/regulations as these relate to laboratory testing, manufacturing processes, and overall data integrity.
• Demonstrated ability to implement risk management tools.
• Experience in oligonucleotide CMC quality oversight desired but not essential.
• Experience in leading quality aspects of product commercialization.
• The successful candidate must be flexible and adaptable to the needs of a small company.

Benefits

Aligos Therapeutics provides a competitive benefits package that includes access to Medical, Dental, and Vision Insurance, Life Insurance, Short- and Long-Term Disability, Health Savings Account (HSA), Flexible Spending Accounts (FSA), Critical Illness, Accident, Legal and ID Theft, 401k plan, PTO, and ESPP (Employee Stock Purchase Plan).

Compensation

The anticipated salary range for fully qualified candidates applying for this role will be $245,000 - $286,000 (not including discretionary bonus, equity, and benefits). The final salary offered will be dependent on several factors that include but are not limited to relevant previous experience including duration and type of experience within the industry, education, and internal equity.

Equal Opportunity Employer

We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity/gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information.

Employment Type

Full-time

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