Manager, Quality Control

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Quality Control Manager, Stability and Materials is responsible for maintaining compliance of the stability program, reserve sample program and QC sample management program. This includes monitoring regulatory stability commitments, performing analyses and preparing documentation for regulatory submissions. This position will have a role in defining and presenting global quality and efficiency metrics. All incumbents are responsible for following applicable Division & Company policies and procedures.

Job Description

• Manages stability and QC sample management program compliance.
• Responsible for QMS documents (e.g. change records, deviations, CAPA), Identifies compliance risks to management, provides remediation proposals, and supports solutions.
• Maintains department metrics.
• Prepares or provides input on new product stability protocols based on available guidances and industry standard practices. Collaborates with development scientist groups, regulatory affairs and quality assurance in preparation of new stability protocols.
• Reviews and approves stability protocols.
• Provides counsel on cGMP stability requirements to colleagues and internal or external customers, with the ability to interpret regulations, guidances, and policies and apply them in the context of compliant execution of the most complex full lifecycle drug development projects.
• Manages the ongoing resolution of deviations and cross functional investigations.
• Reviews and approves stability summary and trend analysis reports.
• Leads teams on continuous improvement initiatives.
• Develops and conducts effective training programs.
• Reviews and approves stability tables, stability summary reports and analyses and submits to the appropriate regulatory contacts.
• Provides responses for Agency requests (e.g., ANDA s deficiency responses).

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

• Bachelors of Science in Chemistry, Microbiology, or other relevant field required (M.S. a plus).
• Scientific Field Typical Experience: 10 years of experience.
• Previous Biologics, biotech or biopharmaceutical experience required.
• Demonstrated quality experience as it relates to quality control systems which integrate FDA/ICH/EU GMPs.
• Previous management or supervisory experience required.

Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Strong knowledge in protein chemistry and standard analytical techniques used in the biopharmaceutical industry (e.g., HPLC, FT-IR, SDS-PAGE, UV-Vis, IEF, Capillary Electrophoresis, ELISA) preferred.
• Working knowledge of cGMP practices, ICH requirements, stability, and validation.
• Understanding of basic statistical analysis and familiarity with the use of databases is desirable.

Skills & Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

• Strong verbal and communication skills with ability to interact with all levels throughout organization.
• In addition, demonstrated excellent interpersonal skills and flexibility, including demonstrated ability for successful leadership, influence and negotiation.
• Ability to coordinate multiple priorities in a fast-paced environment.
• Solid organizational, analytical and problem solving skills

Physical Requirements

Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

• Will have to lift containers weighing approximately 40 pounds.
• Business travel up to 10 % of the time.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

EEO Statement:

At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.