Senior Manager Quality Control

Senior Manager Quality Control – Amgen Singapore Manufacturing Join to apply for the Senior Manager Quality Control role at Amgen . Amgen is one of the world’s leading independent biotechnology companies, with a deep commitment to developing and delivering cutting‐edge therapies to patients worldwide. Japan and the Asia Pacific (JAPAC) region is our fastest growing market. What You Will Do The Senior Manager QC will lead a team within the Amgen Singapore Manufacturing Quality Control organization. Responsibilities include in‐process, release, and stability testing of Amgen products as well as raw material testing. The role reports directly to the Director of Quality Control and is a key member of the leadership team, driving a culture of Safety, Quality, and Lean Leadership. Responsibilities Analytical Testing Teams (General Chemistry, Separation Sciences, Bioassay)Routine testing of Drug Substance In‐Process, Release, and Stability Method validations and transfers Support troubleshooting and problem solving Laboratory investigation and deviation management Site SME for specialized testing Document ownership for testing procedures Quality Control Leadership Team Representation in governance, management review and other forums Innovative projects to advance productivity Compliance with safety guidelines, cGMPs and other applicable regulatory requirements Support staff training, career development and performance management Establish and enable LEAN principles across all areas of responsibility Establish and enable department goals, strategies and KPIs Additional Responsibilities Effectively manage the daily work of direct reports responsible for QC activities Mentor employees by sharing technical expertise and providing feedback and guidance Understand business environment and relate industry knowledge to streamline processes Interface with management on significant matters, often requiring coordination across organizational units Plan and organize project assignments of substantial variety and complexity Initiate or maintain schedule to support QC, network and production requirements Apply systematic approaches and analytical and critical thinking skills for problem solving Identify process gaps, introduce innovative solutions, and lead operational excellence projects to improve efficiency and productivity while reducing costs Lead root cause analysis discussions for complex problems and implement permanent solutions Seek opportunities to permanently improve processes and share best practices with others Qualifications Doctorate degree and 2 years of related experience OR Master’s degree and 6 years of related experience OR Bachelor’s degree and 8 years of related experience AND 2 years of managerial experience directly managing people and/or leading teams, projects, programs or directing resources allocation Working knowledge of cGMP regulations, practices, and trends pertaining to Quality Control Excellent written and verbal communication skills; ability to work in a team matrix environment and build relationships with partners Track record of building or participating in high‐performing teams Experience in leading and owning complex investigations Experience in auditing and defending processes, procedures and decisions during regulatory inspections Experience with laboratory computer systems and applications Strong leadership, negotiation and influence skills with demonstrated ability to work with diverse stakeholders Demonstrated innovative thinking and ability to transform work organizations Strong technical writing skills within a highly regulated environment Exposure to Operational Excellence initiatives Ability to navigate through ambiguity and provide structured problem solving Ability to coordinate multi‐functional project teams and deliver on schedule Skills in staff motivation, coaching/mentoring and professional development Great teammate capable of collaborating and providing leadership through influence to achieve results Benefits Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If selected, you will be informed of the medical check(s) required. All medical related expenses incurred for this check shall be borne by the company. Apply now for a career that defies imagination. Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request an accommodation. #J-18808-Ljbffr