A brief overview
The Director of Quality Control is the leader of 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
- 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
- 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
- Oversee and conduct cGMP, ICH and ISO stability programs to comply with regulatory requirements
- 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
- Investigate and document out-of-specification results and deviations during product testing
- Assure and oversee testing and raw materials, ensure safe, secure, and documented storage of final products in GMP manufacturing
Qualifications
- Master’s degree in chemistry or chemical engineering with a minimum of 5 years’ work experience in GMP manufacturing
- Bachelor’s degree in chemistry or chemical engineering with a minimum of 8 years’ work experience in GMP manufacturing
- PhD in Chemistry (preferred)
- At least 3 years management experience
- Experience with peptides and oligomer manufacturing processes (preferred)
- Experience with Master Control (preferred)
- Experience with SAP (preferred)
- Knowledge of cGMP and FDA regulations
- Exhibit detail-oriented documentation skills
- Excellent written and oral communication skills
- Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
- Detail oriented with the ability to troubleshoot and resolve problems
- Ability to work independently and manage one’s time
- Communicate effectively and ability to function well in a team environment
Base Salary Range: $149,360 - $186,700
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Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.
Total Rewards
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We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.
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Corporate Social Responsibility
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Bachem takes responsibility for future generations by a 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.
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Bachem Americas is an Equal Opportunity Employer
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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
