Director, Quality Control Jobs

A Brief Overview

The Director of Quality Control is the leader of the Quality Control/ Stability laboratory and the Method Transfer/ Validation function. They are the head of Quality Control for the testing of drug substances in compliance with FDA and international regulatory requirements for research, pre-clinical, clinical, and commercial products.

What you will do

• Oversee and conduct cGMP, ICH, and ISO stability programs to comply with regulatory requirements
• Maintain the Quality Control laboratories and stability program per FDA cGMP parts 210 and 211, ICH Q7 and Q9 requirements for drug substances, and ISO 13485 for raw materials used in device and diagnostics
• Investigate and document out-of-specification results and deviations during product testing
• Develop annual master analytical validation plan and ensure validations are conducted per ICH guidelines, including cleaning validations and analytical test method validation
• Ensure continuous improvement and effectiveness of the quality control labs
• Assure and oversee testing and raw materials, ensure safe, secure, and documented storage of final products in GMP manufacturing
• Oversee work of direct reports; distribute workload, and cross-train staff on different quality areas. Interview, hire, train, develop and manage employees
• Oversee the document control function, including issuing records, maintaining electronic and hard copies of master records, and maintaining hard copies of history records

Qualifications

• At least 3 years of management experience required
• Ability to work independently and manage one’s time
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Exhibit detail-oriented documentation skills
• Experience with SAP preferred
• Master's Degree in Chemistry or Chemical Engineering with a minimum of 5 years work experience in GMP manufacturing required or
• Ph.D. in Chemistry preferred
• Ability to effectively organize, multitask, and work in a fast-paced, deadline-driven work environment
• Detail-oriented with the ability to troubleshoot and resolve problems
• Bachelor's Degree in Chemistry or Chemical Engineering with a minimum of 8 years work experience in GMP manufacturing required
• Excellent written and oral communication skills
• Knowledge of cGMP and FDA regulations
• Basic computer knowledge, including Microsoft Word, Excel, and PowerPoint
• Experience with Peptides and Oligomer manufacturing processes preferred
• Experience with Master Control preferred
• Communicate effectively and ability to function well in a team environment

Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation and dedication, we're the right company for you.

Base Annual Salary Range: $141,892 - $195,102

Placement of new hires in the wage range is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, an annual performance bonus, a generous benefits package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.