Manager, Quality Assurance

A Brief Overview
The Manager, Quality Assurance is responsible for Quality Assurance activities including but not limited to batch manufacturing quality oversight, review and approval of GMP documents, batch record review (release of GMP materials), investigations and management of change. In conjunction with the Director of Quality Assurance and Vice President (VP) of Quality Assurance, this individual ensures manufacture of drug substances complies with FDA and international regulatory requirements for research, pre-clinical, clinical and commercial Active Pharmaceutical Ingredients (APIs).

What You Will Do

• Manage QA personnel, including organizing and prioritizing group tasks, performing training, hiring and writing performance reviews
• Develop individuals and team to ensure continuous professional development
• Motivate and coach staff to achieve department goals and business objectives
• Establish and monitor Key Performance Indicators (KPIs) and ensure achievement of goals and business objectives.
• Ensure GMP compliance and continuous improvement of BAM's quality system including identification, facilitation and implementation of improvements.
• Manage QA on the floor processes, including batch record review/release, lead timely closure of GMP systems investigations and management of change and records. Supports QA systems software platforms.
• Support customer & regulatory audits. Participate in responses to audit observations
• Provide leadership and guidance as a QA representative in project teams e.g. harmonization of systems and processes across Bachem sites, implementation of new systems or processes
• Perform other related duties, as required

Qualifications

• Bachelor's degree in science related field or
• Master's degree in science related field (preferred)
• Minimum of 5 years' experience in a GMP/regulated industry
• Minimum of 3 years in a QA management position
• 4-6 years' experience in a GMP manufacturing environment, Quality Assurance or Quality Control
• 4-6 years' experience with 21 CFR Parts 110, 111, 210, 211, ICH Q7
• 4-6 years' experience with GMP document control (preferred)
• 4-6 years' experience in both internal and external auditing (preferred)
• Knowledge of cGMP and FDA regulations
• Analytical decision making
• Ability to effectively organize, lead the work of others, 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 critical issues
• Ability to support regulatory agencies
• Strong technical writing skills, including excellent written and oral communication skills
• Detail oriented with the ability to troubleshoot and resolve problems
• Ability to work independently and manage one's time
• Moderate computer knowledge, including Microsoft Word, Excel, and PowerPoint
• Ability to navigate SAP, Master Control and LIMS

Base salary range:
$116,992 - $160,864

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.