Director of Quality Assurance

Employer
Bachem
Location
Vista, CA
Posted
Apr 29, 2021
Ref
662528101
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides

In order to continue our organic growth, we are constantly looking for talent.

Your Responsibilities

The Director of Quality Assurance, 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 Quality Assurance (QA) personnel, will ensure the review/approval of draft, and executed batch records, specifications, test methods, release and stability data, raw material testing reports, validation protocols and reports, and validation records. This position will also manage systems for tracking of document control, training, internal and external auditing, client audits, CAPAs, and deviations. The Director of Quality Assurance is responsible for coordination with all departments in the company to ensure that timelines are adhered to and company monthly and annual goals are met or exceeded. In addition, this position will be responsible for improving quality systems, processes and procedures to increase the overall level of compliance for the site and business.

Your Tasks

  • Maintain and improve the company’s quality system per FDA ICH Q7 requirements for drug substances
  • Familiarity with 21 CFR 210 and 211
  • Serve as a point of contact with regulatory agencies such as the FDA and foreign regulatory agencies, and participate in regulatory inspections
  • Support customer quality audits
  • Coordinate supplier quality system and ensure critical suppliers are qualified through audits and questionnaires
  • Resolve day to day issues within functional departments and provide compliance assistance as needed
  • Ensure continuous improvement and effectiveness of the quality management system
  • Oversee and conduct GMP, ICH and ISO training to comply with regulatory requirements
  • Oversee CAPA, deviations, NCMR, and product complaint systems and ensure discrepancies are properly documented, investigated and completed in a timely manner
  • 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
  • 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 QA group and recruit, train and manage personnel to meet the quality system and business needs of the company
  • All responsibilities are to be performed in compliance with company policy as well as with applicable domestic and international regulatory requirements
  • Represent QA on project teams

Your Profile

  • Bachelor’s Degree in Science related field
  • At least 10 years’ work experience in a Quality field for GMP company
  • At least 5 years management experience
  • ASQ, CQA and/or CQE certification desired
  • Knowledge of GMP, ISO, Regulatory and FDA regulations
  • Ability to direct, mentor and motivate others
  • Excellent written and oral communication skills
  • 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
  • Ability to work independently and manage one’s time
  • 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
  • Familiar with implementing Lean and Six Sigma concepts

Preferred:

  • Masters or Ph.D. in Science related field
  • Current knowledge of drug development activities in North America
  • Familiarity with EU GMPs

We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are

looking for a new challenge and want to join a motivated team in an internationally renowned company,

you should seize this opportunity.