Program Manager - Quality Systems
Bachem. Pioneering Partner for Peptides
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe and the US, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership.
The Program Manager fulfills a critical role for the Central Function Quality Systems group. This individual will be responsible for assisting with the development/ harmonization of Quality Systems at Bachem US sites and subsequent maintenance and oversight of these systems. This position will collaborate with QA and other team members at sites in the US and Europe to implement different modules of MasterControl, an electronic quality management system (or other electronic tracking tools). This position will also assist with preparing the US sites for regulatory inspections and conducting audits on behalf of Bachem America sites. The incumbent will assist with developing metrics and issuing reports to assess the health of Bachem US quality systems.
Essential Functions and Responsibilities:
· Develop metrics for Quality Systems in support of management review and various quality reports
· Assist with creation of shared Quality Systems documents for Bachem Americas sites to achieve harmonization
· Assist with implementation of different modules of Master Control software at Bachem US
· As part of the Central Function Quality System team you may be required to assist with maintenance/oversight of some of the following Quality Systems:
o Quality Event Reporting
o Document Management System
o Change Control/Equipment Change Control
o Data integrity program
o Supplier Quality program
o Material Qualification Program
o Internal audit program
o External audit program
o Annual Product Review
· Bachelor’s Degree in a science related field – Chemistry, Biology or equivalent
· Minimum of 5 to 8 years of experience in quality assurance
· Extensive experience in cGMP manufacturing, Quality Control, or Quality Assurance
· Experience in writing standard operating procedures, specifications and technical reports
· Experience conducting audits
· Experience with the Material Qualification process
· Experience in developing quality system metrics
· Technical writing experience
· Excellent written and oral communication skills
· Excellent computer skills, including Microsoft Word, Excel and PowerPoint and Access
· 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
· Ability to interact well with co-workers, customers, regulatory agency auditors and senior management
· Communicate effectively and ability to function well in a team environment
· Master’s Degree in Science related field
What We Offer
An exciting opportunity to dive in and begin your career with a company that offers a competitive total rewards package that includes:
· Full range of health benefits including medical, dental, vision and long-term disability
· 401(K) Safe Harbor Plan (3% company contribution, 100% vested)
· iPay Incentive Plan
· 11 Paid Company Holidays, Personal Time, Sick Leave and Vacation Time
· Travel to Switzerland for certain key positions
· Company sponsored events! (Summer BBQ and Holiday Party)
· Generous product discounts
Bachem recognizes that highly motivated and well-qualified employees are its most important asset. The competence, motivation and performance of individuals and the team are key to the development and long-term success of our business. We therefore strive to attract, retain and develop talented and committed people to all of our Group Companies. Bachem ensures equal opportunities for its employees and will not tolerate any discrimination.
This position requires the employee to regularly stand, walk, sit and talk or hear. The employee must also be capable of writing, using a computer keyboard, telephone and related office equipment. The ability to lift up to 25 lbs. is required.
The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Within the facility, the employee will experience normal office conditions with a well- lighted work area and minor noise from standard office equipment. Occasionally the employee will experience unpleasant odors from the manufacturing facility. On a daily basis, the employee will visit the manufacturing facility several times. Lab coat and goggles will be required for these visits. The employee will constantly experience laboratory hazards. Very occasionally, the employee will be called upon to address emergency situations.