Senior Quality Assurance Manager

Breckenridge Pharmaceutical; Berkeley Heights (NJ); On-site; USD 120,000 - 145,000; Full time

Benefits offered by this job

Health benefits

Flexible work approach

Competitive compensation packages

Job summary

A pharmaceutical company in New Jersey is seeking a Quality Assurance Manager to oversee cGMP compliance for contract manufacturers and manage quality systems. Ideal candidates should have a Bachelor's degree in a technical field, at least 10 years of experience in the industry, and strong leadership skills. The position offers a salary between $120,000 and $145,000 annually, with additional health benefits and a flexible work approach.

Qualifications

• Minimum 10 years’ experience in the pharmaceutical industry focused on Quality Assurance.
• At least 5 years in a QA-management role.
• Ability to travel domestically and potentially internationally.

Responsibilities

• Assess third-party vendor cGMP compliance.
• Manage the SOP system, including revisions and training.
• Support FDA audits and inspections.
• Manage and resolve batch deviations and reviews.

Skills

Knowledge of drug production quality and compliance

Knowledge of cGMP regulations

Leadership skills

Attention to detail

Communication and interpersonal skills

Education

Bachelor of Science in a technical/science field

Job description

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.

About the Role

This position reports to the Vice President, Quality Assurance and will manage or support: cGMP compliance assessment of contract manufacturers, the company SOP and Training systems, QA/QC Testing /Audit program, and Quality/Compliance decisions related to the Company’s ANDA products, as well as its products subject to OTC Monographs and FDA or other industry-accepted standards for Dietary Supplements, Medical Foods or Foods for special dietary use.

Responsibilities

• Perform, support and evaluate third party audits of current and proposed vendors for cGMP compliance
• Manage the SOP system, including writing/ revising and maintaining SOPs, SOP Tracking and SOP Training
• Support market distribution of batches
• Manage the review and resolve batch deviations / Out-of-Specification (OOS) reports and proposed Corrective and Preventative Actions (CAPAs) from manufacturers for Dietary Supplements and Medical Foods
• Support FDA audits/inspections of the company or its manufacturing partners, as needed
• Product Quality Reviews, including review of manufacturers' reports of annual product reviews
• Manage change control review of Dietary Supplements and Medical Foods products
• Batch record reviews, as required

Qualifications

• Bachelor of Science required (preferably technical / science-biology, chemistry, pharmacy or other suitable science/technology)
• Minimum 10 years’ experience in the pharmaceutical industry with focus in Quality Assurance / Quality Systems (preferably at least 5 years in a QA-management role)
• Ability to travel domestically 3-4 times per year to perform audits on facilities, potential international travel

Required Skills

• Strong knowledge of quality and compliance for drug production
• Strong knowledge of cGMP regulations (21 CFR 210 and 211 and 21 CFR 110 and 111)
• Strong leadership skills
• Excellent attention to detail and organizational skills
• Effective communication and interpersonal skills

Pay range and compensation package

At Breckenridge Pharmaceutical Inc, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefits programs vary but we offer the following to all BPI team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off programs
• Competitive compensation packages
• The anticipated annual salary for this role is $120,000 – 145,000

Equal Opportunity Statement

Breckenridge Pharmaceutical, Inc is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.