Director, Quality Control

General InformationCountry United States City Irvine, California Functional Area Research & Development Job Group Analytics Employment Type Permanent Contract Working time Full-time At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make Siegfried an attractive employer. Your role Manage quality control activities related to chemistry, microbiology, and raw material inspection testing for all product lines. Supervise the microbiology, chemistry and QC Raw Materials laboratory staff. Responsibilities Develop and improve analytical test methods for incoming material, in-process and final product release. Develop and implement quality control standards. Ensure adherence of all QC staff to quality (GMP) and safety (SHE) requirements at all times. Manage resources and schedule tests in chemistry and microbiology labs to ensure on time execution. Collaborate with QA, MS&T and Engineering groups to develop and finalize testing requirements and specifications for incoming material, in-process and final product release criteria. Identify process and quality problems, recommend solutions, develop or recommend process improvements and assist with implementation in QC. Interact with contract test laboratories in development of off-site test methods. Oversee routine external testing performed at contract test laboratories. Interact with customer on contract testing services provided by the chemistry and microbiology laboratories. Oversee and delegate the necessary testing in the microbiology, chemistry and raw materials laboratories. Review and verify analytical test results from both in-house and contract laboratories. Write, revise, review and approve documentation related to test method validation / verification and stability. Oversight over stability program for internal and customer projects, manage or delegate oversight of the LIMS stability database for stability time points and inventory. Manage the availability of the stability chambers and incubators. Execute responsibilities as QC Director in Labware LIMS. Oversee inspection, sampling and testing of raw materials and final products. Support Cleaning Validation Program Acquire and qualify new equipment for testing of Raw Materials and Finished Products. Support all regulatory submissions of the customers. Support regulatory inspection and customer audit activities. Provide leadership, development and direction to the microbiology, chemistry and raw materials laboratory staff and supervisors. Hire staff that is technically capable to carry out the related job duties. Manage the headcount and laboratory supplies according to requirements and the agreed annual budget. Support the annual budgeting process for headcount, materials and maintenance costs as well as CAPEX. Collect and evaluate KPIs (key performance indicators), report to senior management and global head of QC. Devise and implement corrective actions where necessary. Be part of the SLT (site leadership team) and collaborate with peers to improve the efficiency of the site. Be part of the Global Analytics team and exchange with peers from other sites to harmonize processes, support and learn from best practices. All other duties assigned by the immediate supervisor. Your profile Required Knowledge, Skills and Abilities Strong skills dealing with the FDA and ISO agencies Ability to be involved in all related audits Strong skills presenting QC in front of customers Understand the GMP requirement for medical device / pharmaceutical industry, with quality control / compliance background. Excellent knowledge of analytical test methodologies and stability studies. Strong technical and problem-solving skills. Economical thinking and OPEX oriented mindset. Ability to coordinate multiple responsibilities and activities simultaneously. Must have strong communication, leadership, and interpersonal skills. Must be comfortable working in a dynamic environment with changing priorities Required Education and Experience Bachelor Degree in Advance Degree in Chemistry or Microbiology, Advanced Degree preferred 10 years of related experience Target Salary Range : $160,000 - 170,000Working at Siegfried Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs. Who we are In the Midst of People's Lives - Across the Globe The Siegfried Group is one of the world's leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model. The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers' value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production. We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products. What we do in Irvine Irvine is one of Siegfried's sterile drug product manufacturing sites, providing contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices. Main activities Provides cGMP sterile drug product fill finish of biologics, suspensions, emulsions, ointments, and gels All fully cGMP and SHE compliant Features Commercial Products : 5 automated filling lines, Commercial manufacturing, Batch sizes up to 150 K units, Fill Volumes 0.5 ml - 100 ml Semi-automated and automated visual inspection Automated packaging with digital data visual verification Stability study services Drug delivery Laboratory services Clinical Products small lot capability (semi-automated filling, batch sizes up to 5 K units) Clinical manufacturing (batch sizes less than 5 K units) Strategic importance CDMO for innovative and difficult-to-manufacture products from clinical to commercial NDA and ANDA products Provides contract sterile drug product manufacturing and laboratory services to the pharmaceutical and biotechnology industries

Salary : $160,000 - $170,000