Quality Assurance Manager

Position Title : Quality Assurance Manager

Department: Quality Assurance

Reports To: Director, Quality Assurance

Work Location: East Brunswick, New Jersey, United States

Position Summary:

The Quality Assurance Manager is responsible for overseeing the implementation and maintenance of quality systems that ensure pharmaceutical products meet all regulatory and company standards. This role manages QA operations, leads continuous improvement initiatives, and ensures compliance with cGMP and relevant regulatory requirements.

Responsibilities:

• Maintain and prepare local Standard Operating Procedures (SOPs) and associated forms, Internal Document Change Controls, Master Finished Product Specifications, MSDS and SDS Documents
• Maintain Document Management System (DMS) – create and update SOP’s, Quality Agreements and SDEA’s
• Maintain Quality Agreements
• Responsible for organizing and archiving cGMP documents
• Compile and report monthly metrics for Quality Assurance
• Maintain training matrix for all active positions
• Perform audits, both internal and external. Maintain audit schedule for domestic partners
• Review Certificates of Analysis and any applicable release documentation, e.g. Certificates of Compliance, Certificates of Conformance, Temperature Data Logger, etc.
• Review Manufacturing/Packaging Batch Records for Rising-ANDA products.
• Perform product disposition/ initiate activities related to product quarantine, release, reject and destruction.
• Manage SOP Manual and periodic SOP revisions as well as drafting new SOP’s.
• Train Rising employees on local SOPs and associated forms as needed.
• Support the team with review of tech-transfer protocols, master batch records, validation reports, and stability data.
• Assist with review of analytical test methods, specifications and method validation protocols and reports.
• Assist with implementation of e-QMS modules if required.
• Assist with investigations and deviations received from the manufacturing partners as well as initiate and write internal investigation reports.
• Assist with change management and review and assessment of change controls from contract manufacturing partners.
• Ensure compliance with DSCSA requirements for serialization
• Support with Recall Management as required.

Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field; advanced degree preferred.
• 10 years of experience in pharmaceutical quality assurance, including supervisory or management roles.
• Strong knowledge of cGMP and regulatory compliance standards.
• Experience with quality systems such as CAPA, deviation management, and change control.
• Excellent leadership, communication, and organizational skills.
• Detail-oriented with strong analytical and problem-solving abilities.
• Proficient in quality management systems and Microsoft Office.
• Ability to work effectively in a fast-paced, regulated environment.

Salary Range:

$80,000-$90,000

Benefits:

Retirement and Financial Planning:

• 401(k) Plan with company match
• Health Savings Account (HSA)
• Flexible Spending Accounts (FSA)
• Social Security
• Unemployment Compensation Insurance
• Supplemental Life Insurance
• Accidental Death & Dismemberment Insurance
• Employer Paid Life Insurance

Health and Insurance Coverage:

• Health, Dental, and Vision Insurance
• Dependents' Health Care Coverage
• Dental Care Coverage
• Vision Care Coverage
• Critical Illness Insurance
• Long-Term Disability Insurance
• Short-Term Disability Insurance (Company paid for employees in states that do not offer state-provided Short-Term Disability)
• Workers’ Compensation
• Hospital Indemnity
• Group Term Life Insurance
• Supplemental Life Insurance

Retirement and Financial Planning:

• 401(k) Plan with company match
• Health Savings Account (HSA)
• Flexible Spending Accounts (FSA)
• Social Security
• Unemployment Compensation Insurance
• Supplemental Life Insurance
• Accidental Death & Dismemberment Insurance
• Employer Paid Life Insurance

Health and Insurance Coverage:

• Health, Dental, and Vision Insurance
• Dependents' Health Care Coverage
• Dental Care Coverage
• Vision Care Coverage
• Critical Illness Insurance
• Long-Term Disability Insurance
• Short-Term Disability Insurance (Company paid for employees in states that do not offer state-provided Short-Term Disability)
• Workers’ Compensation
• Hospital Indemnity
• Group Term Life Insurance
• Supplemental Life Insurance

Leave and Time Off:

• Vacation
• Sick/Paid Time Off
• Federal Holidays (10 days off for recognized federal holidays)
• Family and Medical Leave
• Short-Term Disability (Company paid for employees in states without state-provided coverage)

Professional Development and Well-being:

• Professional Development Opportunities
• Child and Dependent Care
• Flexible Benefits Plan
• Identity Protection Plan
• Legal Services Plan
• Medical Expense Accounts

Physical Demands and Work Environment:

• While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.

Safety Requirements:

• Follow all company safety policies and procedures.
• Proper use of personal protective equipment (PPE) as required (e.g., gloves, goggles, etc.).
• Adherence to safe handling protocols for equipment and materials.
• Participation in safety training and emergency response drills as needed.

Disclaimer:

The list of essential functions and additional responsibilities provided is not exhaustive and reflects the most current and accurate duties of the position. Management reserves the right to revise the job description and require other tasks as needed, in response to changing job circumstances.

This position description does not imply an employment contract. Requirements are the minimum levels of knowledge, skills, and abilities required for the role. Successful performance of the duties will require the employee to demonstrate the abilities to execute tasks proficiently. Employment decisions, including promotions and transfers, are based on meeting these criteria and organizational needs. The methods for fulfilling these requirements may be modified to reasonably accommodate qualified individuals with disabilities.

Employment is considered "at-will," meaning either the employee or the company may terminate the employment relationship at any time, with or without cause, and with or without notice, unless otherwise required by law.