Do you have a strong background in API's and experience building out quality systems to support ongoing production? Want to work in a brand-new facility of a global Biotech leader with amazing Scientists and Engineers as colleagues? This could be the perfect role for you!
What You'll Do:
The Manager, Quality Assurance – API is responsible for providing the direction and leadership for quality assurance processes for product quality and GMP compliance of contract manufactured Active Pharmaceutical Ingredient (API) products. This will include:
– Manage QA staff involved in key processes such as CAPA, Nonconformances, Change Control, Audit, Training, and Document Control & and Records related to the manufacture of API products.
– Design, develop, and manage key quality system processes to ensure compliance with the requirements for API products.
– Work with QA leadership to improve quality system processes and overall quality and regulatory activities.
– Participate in both internal and external audits; play an active role in maintaining an inspection ready state.
– Represent the company in discussions/interactions with regulatory bodies, partners, vendors, or customers.
– Actively coach, mentor and develop team members and leaders within the department.
– Lead and support cross-departmental, corporate, and team projects and initiatives.
– Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Act with kindness, curiosity and respect for others.
– Understand and comply with ethical, legal and regulatory requirements applicable to our business.
What You'll Bring:
– University degree (B.S. or M.S.) in a biological or chemical science or other relevant field.
– Minimum of 10 years related experience in quality control, quality assurance, product support, or manufacturing.
– Working knowledge of quality standards governing API products including 21 CFR 210 & 211 and ICH Q7.
– Ability to understand basic statistical concepts and analytical data.
– Ability to communicate (in written and oral forms) in a concise, clear, and accurate manner.
– Proven ability to work constructively with a broad range of people, backgrounds, and functions.
– Ability to perform analysis of complex problems or data requiring in-depth evaluation of various factors.
– Exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
– Proficient with electronic tools including Microsoft Office applications and eQMS programs.
– Technical knowledge or experience in scientific areas specifically applicable to small molecule drug manufacturing.
– Previous experience managing FDA inspections.
Apply Now and move your career forward with an exciting and highly respected biotech leader!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com
Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.