Manager, Manufacturing Product Quality – Small Molecule

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise the production of commercial and clinical products at contract manufacturers, ensuring compliance with GMP and global regulatory standards.

• Conduct batch record evaluations and quality release tasks for API, drug products, and final finished goods.

• Assist in the qualification and oversight of external contract manufacturing vendors, including conducting audits and performance assessments.

• Review and authorize GMP documentation, encompassing batch records, labels, and packaging specifications.

• Guarantee that manufacturing, packaging, and labeling standards are applied consistently across commercial products and global clinical trials.

• Offer quality oversight for QC activities, including release/stability data, method development and validation, testing protocols/reports, method transfers, and testing procedures.

• Collaborate with the Commercial and Clinical Supply Chain as well as Regulatory Affairs to ensure compliant delivery of clinical materials.

• Assist in deviation investigations, implementation of CAPA, and change control related to manufacturing.

• Maintain and revise SOPs, work instructions, and quality documentation for manufacturing and packaging processes.

• Work with cross-functional teams to compile the Annual Product Quality Review for commercial products.

• Provide training and support to both internal teams and external partners regarding quality requirements.

• Engage in quality-system evaluations and enhancement initiatives.

• Prepare and contribute to quality metrics and management reports.

⛳️ Requirements

• A Bachelor’s degree in Chemistry, Engineering, Life Sciences, or a related discipline.

• At least 5 years of experience in a regulated environment, particularly within the pharmaceutical or medical device sectors.

• 3 to 5 years of experience in Quality Assurance or Supplier Quality positions.

• Knowledge of FDA 21 CFR Parts 210, 211, 820, and Part 11 regulations.

• Excellent organizational and communication skills.

• Capability to handle multiple tasks and collaborate effectively in a team setting.

• Proficiency in MS Word, Excel, and Access.

• Experience with quality systems such as TrackWise is beneficial.

• Willingness to travel up to 20% of the time.

🏝️ Benefits

• Incentive opportunity.

• Comprehensive medical coverage.

• Dental coverage.

• Vision coverage.

• Prescription drug coverage.

• Company-sponsored basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term disability insurance.

• Long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching.

• Flexible time off.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.