Sr. Manager, Supplier Quality Assurance

Description

• Responsible for providing the direction and integrity of the Quality Assurance processes intended to deliver product/process quality requirements. Provide technical support for the company development partners and commercial customers. Implementation of first batch new product launches at the manufacturing site as part of technology transfer.

• Audit processes/procedures to ensure a compliant finished product, as required by regulation or product process procedures.

• Oversees the Central Life Sciences continuous improvement processes, ensuring timely implementation of corrective and/or preventive actions for contract suppliers.
• Coach contract suppliers to Central Life Sciences expectations and requirements.
• Ensures applicable requirements (i.e. ISO 9001:2015; cGMP for both US FDA and VICH harmonized guidelines; and/or US EPA and OCED harmonized guidelines) are in compliance.

• Manage and oversee Quality Agreements for EU/Japan Drug Active Pharmaceuticals and Drug Products. Training and competency in contract negotiations is very important to ensure the terms outlined comply with regulatory requirements.
• Identify and propose remedies for a breach of contract of quality agreements.
• Serves as the responsible person for quality contracts, in addition to the identified upper management representative, as the QA representative for contract compliance.
• Provide support to Central Life Sciences Professional Brands customer base.
• Cross functional support of Research & Development, Regulatory, Sales/Marketing and Operations department projects, as assigned.
• Provide guidance and direction for compliant manufacturing of products regulated by FSMA.

• The ability to effectively communicate (verbal and written) with all levels of the company, to interact well with other departments and co-workers, and to accept guidance from senior members of staff.
• Must understand analytical chemistry laboratory work; capable of thinking logically.
• Possess a good working knowledge of word processing, spreadsheet, and other computer software skills; able to use laboratory computer systems, office computer systems and applications effectively.
• Familiarity with the use of laboratory instruments used for physical and chemical testing.
• The ability to review and approve batch records and related documents used for commercial release of product.

• Bachelor's degree in chemistry or equivalent field required

• A high competence in analytical chemistry is required. Aspects of organic chemistry, physical chemistry, and mathematics such as calculus, algebra and statistics supporting experimental design and approaches to problem solving also needed

• At least 7 years of related quality assurance experience required
• ASQ certifications are highly desirable

• Knowledge of chemical synthesis, cGMPs and processes

• Experience conducting third party manufacturing audits
• The highest degree of confidentiality and discretion required. Integrity must be beyond reproach.
• Knowledge and understanding of FSMA (the FDA Food Safety and Modernization Act) is highly desired.

• Much time is spent on computer and deskwork.
• Safety apparel is required in the lab or production areas, i.e. safety glasses (always), lab coat, gloves, dust masks (as appropriate).
• Standard procedures must be carefully followed in working with potentially hazardous equipment and materials. There is exposure to equipment and materials at extremely high temperatures, and cryogenic temperatures (liquid nitrogen). Appreciation for the safe handling of flammable liquids, compressed gases, acids, bases, and toxic chemicals is required.
• The use of a hard hat, respirator mask, and other safety equipment is necessary at times.

• Comprehensive Medical, Dental, and Vision Insurance
• Free Life and Disability Insurance
• Health and Dependent Care Flexible Spending Accounts
• 401k with 3% company match
• Paid vacation, holidays and sick time
• Employee Assistance Program
• Access to thousands of free online courses
• Discounts on cell phones, movie tickets, gym memberships, and more!
• Education Assistance (both college degrees and professional certifications)
• Referral Program with cash bonus
• Access to on-demand pay
• Paid parental leave