Kashiv Pharma, LLC. Manager, QA Compliance in Chicago, Illinois
Adello Biologics is a privately held, U.S.-based biotechnology company that leads with science to accelerate development and drive manufacturing efficiency. The company's aim is to provide high-quality, affordable biosimilars to patients worldwide. Headquartered in Piscataway, NJ and driven by a team of highly skilled industry veterans, Adello is advancing a strategic pipeline of proteins and complex monoclonal antibodies with lead candidates in oncology and immunology. For more information, visit www.Adellobio.com
Our vision is to make biosimilar medications affordable. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Adello Biologics offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career. We are seeking a Manager, QA Compliance to be based out of our Chicago, IL location.
- The Compliance Manager, QA, is a regular employee in a full-time exempt position at Adello Biologics, LLC, in Chicago, IL. The employee is in charge of supervising and managing the Quality Assurance compliance function in the QA department. This role will oversee and direct the activities of the Supplier Quality Management and Audit Programs. Works with the head of Quality Assurance to oversee, implement and maintain CGMP compliant systems. Provides the functional and strategic leadership to ensure Adello’s Quality Systems and procedures are in a state of control and meet with industry standards. Manages a broad spectrum of projects to support the needs of Quality Management. This position interacts with all departments within Adello and with suppliers globally as well as within the US.
Essential Duties and Responsibilities:
Oversees the development and implementation of Quality Assurance procedures governing the facility Quality Systems and ensures compliance with cGMP regulations, customer expectations and company policies.
Oversees the Supplier Quality function and ensures procedures and systems are in place to evaluate, control and monitor incoming product quality. Ensures suppliers are thoroughly evaluated, scrutinized and approved per procedures to ensure incoming material meet Adello standards and CGMP.
Manages and leads the Internal Audit program to monitor Adello’s state of compliance. Identifies and resolves any nonconformance issues and ensures audit findings are addressed in a timely manner.
Oversees the external audit program and conducts supplier audits globally as well as within the US. Maintains strong supplier relations and interfaces with suppliers to resolve any Quality findings, Supplier Complaints etc.
Prepares and manages audit schedules, audit plans and agenda, audit reports and responses.
Leads Quality Investigations and prepares investigation reports. Collaborates with cross functional teams to resolve Quality issues, identify root cause and implement necessary CAPAs.
Performs gap assessments, generates Quality and Compliance plan and drives implementation of Quality objectives.
Monitors effectiveness of Quality Systems, generates Quality System event metrics and trend analysis for management review, escalates issues and drives resolution.
Liaises with customers, CMOs, regulatory authorities, third party auditors and suppliers regarding quality matters including hosting inspections and preparing audit responses.
Involved in developing, modifying and executing company policies that affect immediate operations and may also have companywide effect.
Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
Has familiarity with USP, cGMP, ISO, Code of Federal Regulations (CFR) guidelines and ICH guidelines.
Other duties as requested by management.
Education / Experience:
BS degree in life sciences (Biology, Chemistry, etc.) with 5-7 years’ relevant industry (Biotech/Pharma) experience.
MS degree in life sciences with 3-5 years’ relevant industry (Biotech/Pharma) experience.
Knowledge of GMPs and their application in the commercial environment is required.
Working experience in an aseptic processing facility.
- ASQ certified quality auditor (CQA) preferred
SPECIALIZED KNOWLEDGE AND SKILLS:
Ability to work independently or in teams both within department and cross-functionally. Must be able to organize, plan and manage assigned tasks to bring projects to completion.
Strong and clear communication skills, both written and verbal.
Presentation of data and reports to small/large groups is part of the job.
Excellent organizational skills and detail oriented. Must have excellent time management skills and the ability to effectively prioritize assignments.
Requires the ability to influence and change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
Exercises due professional care and works with a high level of integrity.
Excellent computer skills in Microsoft Office applications.
WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:
Typing, desk work and plant auditing 8-10 hours/day.
Some brief and/or minimal exposure to hazardous chemicals may occur, requiring personal protective equipment.
Safety alertness is required due to work around hazardous equipment and conditions.
Travel may be required for supplier audits, approx. 20-30% of work time.
- Noise levels commensurate with shared office space.
- No extraordinary requirements
- No extraordinary requirements.
- High-paced demanding environment to meet ambitious project goals.
- Approximately 20-30% of work time
Adello Biologics is now Kashiv BioScience. If you would like to apply to this position, please copy and paste the direct link below to the Kashiv Career page, where you can apply.
Adello Biologics, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Adello Biologics, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.
Notice To Agency And Search Firm Representatives
Adello Biologics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Adello employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Adello. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
External Company Name: Amneal Enterprises LLC
External Company URL: http://amneal.com/
Street: 3440 S. Dearborn Street, Suite 300