Amgen Sr Mgr QA - AML 6 Drug Substance Operations in Juncos, Puerto Rico

SUMMARY

We are seeking a highly motivated individual to join us as Senior Manager, Quality to manage the activities of the plant Quality Assurance department in our multi-product mammalian cell culture facility located in Juncos, Puerto Rico. A strong foundation in application of GMPs in a drug substance or drug product manufacturing environment is critical, to quickly assess facts and make the appropriate decision when process/product quality may be impacted. The selected individual will manage Quality staff including recruitment and performance management as well as oversee aspects of QA operations within the facility, including but not limited to batch record review, on-the-floor QA support, deviation investigations, change controls, and SOP and batch record review. Ability to work in cross functional teams including Manufacturing Operations, Process Development, Supply Chain and Quality Control is required. Applies quality/manufacturing experience, including process validation, to ensure that operations meet customer and regulatory expectations and will provide guidance for significant quality issues during non standard shifts.

SPECIFIC RESPOSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

  • Responsible for leading and directing the Quality Assurance functions for assigned plant or functional area(s)

  • Responsible for providing Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations

  • Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations

  • Responsible for Quality disposition (approval or rejection) of raw materials and components, bulk drug substances, bulk drug products, and finished product for assigned areas

  • Ensures the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records, including Nonconformances, CAPAs, and validations

  • Supports Continual Improvement initiatives, programs and projects

  • Ensures that changes that could potentially impact product quality are assessed according to procedures

  • Ensures that deviations from established procedures are investigated and documented per procedures

  • Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements

  • Ensures that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks

  • Ensures that Quality Assurance personnel are qualified and trained to perform assigned functions in accordance with cGMP with requirements

  • Ensures the Quality Management System is implemented, maintained and reviewed in accordance with cGMP regulations

  • Alerts senior management of significant quality, compliance, supply and safety risks

  • Develops area budget and manages expenditures

EDUCATION/LICENSES

Doctorate degree and 2 years of GMP regulated environment experience

OR

Master's degree and 6 years of GMP regulated environment experience

OR

Bachelor's degree 8 years of GMP regulated environment experience

AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

PREFERRED QUALIFICATION:

  • Educational background in Biology or Chemistry or Biochemistry or Engineering

  • Quality experience

  • Demonstrated ability to manage supervisors.

  • Ability to delegate wisely and effectively.

  • Works effectively with diverse departmental groups.

  • Excellent team development and leadership skills.

  • Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, Quality Control, validation, and process development.

  • Commands respect from team, peers, and management.

  • Thorough knowledge of CFRs, GMPs and pharmaceutical processing and demonstrated ability to apply.

  • Able to make sound, quality decisions independently.

  • Excellent communication (both written and verbal), facilitation, and presentation skills.

  • Skilled in risk management

  • Demonstrate the Amgen Values/Leadership Practices

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.