Program Manager - Quality Systems Validation

Employer
Bachem
Location
Torrance, CA
Posted
Jul 09, 2018
Required Education
Bachelors Degree
Position Type
Full time

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.

Job Summary:

The Program Manager fulfills a critical role for the Central Function Quality Systems group.  This individual will be responsible for assisting with the development and harmonization of Quality Systems at the Bachem US sites, as well as subsequent maintenance and oversight of these systems. This position will collaborate with Quality Assurance and other team members at sites in the US and Europe to implement different modules of Master Control, an electronic quality management system. The incumbent will be responsible for leading the harmonization of quality systems such as: the validation program, material qualification, and critical work order processes at the Bachem US sites.  The incumbent will oversee and ensure the adequacy of the Validation Maintenance program.  This position will also assist with preparing the US sites for regulatory inspections.  The incumbent will assist with developing metrics and issuing reports to assess the health of the Bachem US quality systems.

Essential Functions and Responsibilities:

  • Assist with the creation of shared Quality Systems documents for Bachem Americas to achieve harmonization between the Torrance and Vista sites
  • Assist with the implementation of different modules of Master Control software
  • Assist with maintenance/oversight of the following Quality Systems:
  • Quality Event Reporting
  • Document Management System
  • Change Control/Equipment Change Control
  • Data integrity program
  • Supplier Quality program
  • Material Qualification Program 
  • Validation practices
  • Internal audit program
  • External audit program
  • Annual Product Review

Minimum Qualifications:

  • Bachelor’s Degree in a Science related field (Chemistry, Biology or equivalent)
  • Minimum of 5 years of experience in quality assurance
  • Extensive experience in cGMP manufacturing, Quality Control, or Quality Assurance
  • Experience in Validation and Qualification activities related to process, equipment, critical systems and cleaning
  • Experience with establishing requirements and design of validation master plans
  • Experience with IQ, OQ and PQ protocols and reports
  • Experience in writing standard operating procedures, specifications, validation protocol reports and technical reports
  • Experience with developing quality system metrics
  • Ability to interact well with co-workers, customers, regulatory agency auditors and senior management
  • Technical writing experience
  • Excellent written and oral communication skills
  • Excellent computer skills with emphasis on Microsoft Word, Excel 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 technical and analytical problems
  • Ability to work independently and manage one’s time
  • Communicate effectively and ability to function well in a team environment

Preferred:

  • Experience with Master Control or other electronic quality management system
  • Master’s Degree in a 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

Our Values

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.

Physical Requirements:

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.

Environmental Conditions:

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.