Manager QA - AML 6

SUMMARY

We are looking for 2 highly motivated and hardworking Managers QA for our manufacturing operation at Puerto Rico site, Amgen Manufacturing Limited - a state-of-the-art biotechnology facility. As Manager QA you will be responsible for leading and supervising the Quality Assurance area in a mammalian cell culture facility in a Non-Standard Shift.

The AML-6 Facility is the home of best-in-class, multi-product Drug Substance Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a culture of opportunities integrating cross-functional teams from across the site with the goal of achieving being the best manufacturing facility in the world.

The Role

You'll be accountable to apply a combination of managerial tasks, supervision and Good Manufacturing Practices in a drug substance manufacturing environment to quickly assess facts and make the appropriate decision when process/product quality may be impacted.

Consistent with our core leadership value of "Develops the Best Team," we are seeking leaders that prioritize the development of talent. We expect managers to exemplify strong leadership and champion self-awareness and career development. Ways that you will get to display your leadership acumen and Quality expertise in this role include:

• Direct management on-the-floor of QA activities including but not limited to batch record review, deviation investigation, change controls and SOP, among others
• To be successful, you will require strong collaboration and partnership cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures
• Strategic advisor to senior management of quality, compliance, supply and safety risks
• Mentoring, coaching, and developing staff to build highly-skilled, diverse, and inclusive teams
• Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities
• Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement
• Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages
• You'll resolve critical gaps in the organization's internal capabilities and skillsets, including strategic external recruiting as needed
• Identifying diverse, qualified successors for key positions

Additional objectives are:

• Maintaining production in full cGMP compliance
• Evaluate current operating procedures and recommend changes to management to optimize execution
• Ensure maintenance and re-validation of systems,
• Collaborate with cross-functional teams (i.e. Manufacturing, PPIC, PD, Regulatory, etc.) in completing production activities
• Review and approve product MPs, process validation protocols and reports for manufacturing processes, Environmental Characterization reports, planned incidents and change-over completion
• Represent QA on NPI team
• Lead investigations, plant and or site audits
• Sponsor Continuous Improvement initiatives and projects

BASIC QUALIFICATIONS/EDUCATION

Doctor degree

OR

Master's degree and 3 years of Quality experience

OR

Bachelor's degree and 5 years of Quality experience and previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.

PREFERRED QUALIFICATIONS

• Educational background in Life Science or Engineering
• Project management skills
• Initiate and lead cross functional teams
• Validated expertise in Quality Systems such as Non Conformance, CAPA and Change Control
• Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background Technical proficiency)
• Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development
• Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements
• Strong organizational and change management skills
• Good communications skills (oral and written) and comprehend in English and Spanish
• Enhanced skills in leading, influencing and negotiating
• Ability to motivate staff and manage and distribute workloads.
• Demonstrate ability to interact with regulatory agencies
• Solid word processing, presentation, database and spreadsheet application skills
• Strong communication (both written and oral), facilitation and presentation skills
• Proven skill in working independently and to effectively interact with all levels throughout the organization
• Advanced data trending and evaluation
• Ability to evaluate compliance issues

As Manager QA you will be unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering creative 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.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses 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.