Director, Quality Assurance (QS&C)

A brief overview

The Director of Quality Assurance (Quality Systems & Compliance), in conjunction with the VP of Quality, maintains systems to assure compliance regulatory and client requirements for all relevant GMP operations carried out within the organization for the manufacture of drug substances in compliance with FDA and international regulatory requirements for research, pre-clinical, clinical and commercial Active Pharmaceutical Ingredients (APIs).

The person in this role will oversee QA (QS & Compliance) personnel, will manage systems for tracking of document control, training, internal and external auditing, client audits, CAPAs, and deviations. Management Review, Metrics and KPIs as well as data analysis are part of the responsibilities. 

The Director of QA (QS & Compliance) is responsible for coordination with functions across the company that perform activities governed by cGMPs to ensure those activities are conducted in compliance with Bachem's QMS, policies & procedures, and applicable regulatory requirements. In addition, this position will be responsible for improving quality systems, processes and procedures to increase the overall level of compliance for the BAM sites.

What you will do

• Maintain and improve the company’s quality system per FDA ICH Q7 requirements for drug substances
• Manage and participate in regulatory inspections, manage customer Quality audits
• Manage Quality Data Analytics and provide KPI data to QA
• Ensure continuous improvement and effectiveness of the quality management system
• Oversee and conduct GMP, ICH and ISO training to comply with regulatory requirements
• Manage Quality Management Review and APR
• Oversee the document control function, including issuing records, maintaining electronic and hard copies of master records, and maintaining hard copies of history records
• Oversee quality functions, including but not limited to deviations, CAPA, NCMR, annual product quality reviews, calibration program, DCR system, change control system, raw material release, QC record review, stability studies review, and batch record review
• Establish head count needs for the QS / Compliance group and recruit, train and manage personnel to meet the quality system and business needs of the company
• Perform cGMP internal audits and cGMP surveillance across the BAM sites

Qualifications

• Bachelor's degree in organic chemistry or related field or
• Master's in organic chemistry or related field
• 10+ years’ experience in pharmaceutical or medical device industry
• 4-6 years’ managerial experience in cGMP manufacturing
• Knowledge of GMP, ISO, FDA, EU and international regulations
• Ability to direct, mentor and motivate others
• Excellent written and oral communication skills including data analytics
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
• Ability to manage critical projects to deadlines as part of an interdisciplinary team
• 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
• Communicate effectively and ability to function well in a team environment
• Presentation skills, technical writing and editing skills
• Ability and willingness to work flexible/extended hours and moderate travel as needed to support the business

Base salary range: $167,354 - $208,645

Placement of new hires in these wage ranges 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, 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.

 Corporate Social Responsibility

 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 Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.