Job Notice – VP of Quality & Regulatory: Gallus Biopharmaceuticals

JOB SUMMARY VP of Quality & Regulatory:
Leads and manages the Quality & Regulatory organization and all Quality related programs and activities to support site operations. Functions and activities include Quality Control, Quality Assurance, Validation, GMP Training, Compliance and Regulatory. Ensures business, quality and compliance goals are met in full compliance with all Gallus and relevant government issued quality and regulatory policies/guidelines.

REPORTING RELATIONSHIPS Leads: 6-8 Direct Reports & 70-100 Indirect Reports

ACCOUNTABILITIES For setting the standards for current Good Manufacturing Practice (cGMP) Quality for Gallus, by analyzing relevant regulatory authorities laws, standards, programs and activities in areas relevant to biological products. For testing and timely disposition of commercial and clinical material to allow shipment to customers. For measuring, reporting and improving Quality compliance and performance against the Gallus standards. For the compliance of the raw material and consumables vendors against the Gallus standards. For developing an appropriate operating and capital expense budgets and striving to have the Quality organization contribute to Gallus profitability. For supporting the commercial function in the assessment of new opportunities and providing appropriate Quality input to prospective customers, including the demonstration of compliance through audit. Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to ensure that standards are met.

ESSENTIAL JOB FUNCTIONS Proactively develops and sustains strong relationships with regulatory authorities. Directs team of Supervisors, Managers, and Professionals within Quality who are responsible in hiring and developing employees within the department in support of site objectives. Collaborates with internal stakeholders in Manufacturing, Process Development, Project Management, EHS, etc. to facilitate successful customer management. Set and direct organization towards short-term and long-term goals by utilizing Operational Excellence Programs. Desired Skills and Experience

KEY CHARACTERISTICS The individual selected for this role must be independent and have a depth of experience in managing all of the quality aspects associated with clinical and commercial GMP manufacturing. Ability to work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the management of compliance. Strategic leadership and thinking to ensure compliance is delivered cost effectively. Rational persuasion particularly in the discussions with customers. Strong people management and organizational skills; ability to prioritize and manage through complex processes/projects. Ability to read, analyze and interpret business periodicals, common scientific, professional and technical journals, governmental regulations and legal documents. Ability to deal with abstract and concrete variables in situations where only limited standardization exists.

EDUCATION AND QUALIFICATIONS B.S. in a scientific/technical discipline with 15+ years experience in a significant leadership position within the biological and/or pharmaceutical industry, or Ideally a PhD or Masters Degree in scientific/technical discipline with 10+ years experience. At least 10 years experience in a Quality leadership role required Demonstrated strategic leadership of a Quality Organization for a Contract Manufacturer preferred. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.

PHYSICAL DEMANDS Ability to function in a rapidly changing environment and balance multiple priorities simultaneously. A flexible work schedule is required. This role will be based in St. Louis with up to 30% travel likely. This job description is not all inclusive, other duties may be performed as assigned. About this company

Gallus is a mammalian cell culture contract manufacturing organization (CMO) that offers a unique level of flexibility and strategic appeal to companies seeking to develop and manufacture biologics. As a pure-play CMO, we deliver a high level of quality and reliability to our clinical and commercial clients. Our team has nearly three decades of biologics manufacturing experience, combined with an exceptional focus on quality evidenced in a high frequency of tech transfers and a long-term stellar regulatory record. Gallus also demonstrates reliability with an outstanding record of batches starting and releasing on time. We provide value for your molecule in our uniquely flexible services and business models, including utilizing advanced technologies to improve processes, reduce project timelines and optimize yields. We have significantly expanded our process development laboratories and clinical services suites using flexible stainless steel and single-use technologies, and have built our talent pool with industry-recognized expertise in cell culture, purification, analytical development and project management. Combined, Gallus’ team and facilities provide the exceptional service you seek for developing and manufacturing the biologic therapies of the future. The Gallus team is ready to demonstrate our flexibility and how far we’ll go to work for you.

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