Loading...
Share this Job

Director of Quality Assurance

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, the US and Asia, 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.

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

daily 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 and ISO 13485 for raw materials used in

          device and diagnostics

·         Familiarity with 21 CFR 210 and 211

·         Coordinate regulatory documents, such as Chemistry, Manufacturing and Controls (CMC) and Drug Master Files (DMF) to meet FDA cGMP and

           ICH requirements

·         Serve as the secondary point of contact with regulatory agencies such as the FDA and foreign regulatory agencies, and participate in all

          regulatory inspections

·         Host customer quality audits, coordinate quality agreements and change notifications with customers

·         Coordinate supplier quality system and ensure critical suppliers are qualified through audits and questionnaires

·         Develop annual master validation plan and ensure validations are conducted per ICH guidelines, including cleaning validations, process

          validations, facility and equipment qualification, and analytical test method validation

·         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

·         Chair management review meetings and oversee quality improvement plan

·         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

·         Manage or perform other projects as assigned

 

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.


Nearest Major Market: San Diego