Senior Manager Quality Control

Career CategoryQualityJob Description

Senior Manager Quality Control

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world's leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Senior Manager Quality Control in Amgen Singapore Manufacturing.

Live

What you will do

The Senior Manager QC will lead a team in the Amgen Singapore Manufacturing Quality Control organization responsible for in-process, release, and stability testing of Amgen products as well as raw material testing.  The Senior Manager QC will report directly to the Director of Quality Control and as a member of this leadership team will contribute to fostering and further developing the culture of Safety, Quality, and Lean Leadership.

Responsibilities:

The Senior Manager QC will be accountable for the following areas in support of core QC laboratory operations:

Analytical Testing Teams (General Chemistry, Separation Sciences, Bioassay):

• Routine testing (Drug Substance In-Process/Release/Stability)
• Method validations / transfers
• Support troubleshooting and problem solving
• Laboratory Investigation and deviation management
• Site SME's 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 manages the daily work of direct reports responsible for QC activities.
• Mentor employees by sharing technical expertise and providing feedback and guidance.
• Understands business environment and relates industry knowledge to streamline business processes.
• Interfaces with management on significant matters, often requiring the coordination of activity across organizational units and exercises judgment independently.
• Plans and organizes project assignments of substantial variety and complexity.
• Initiates or maintains schedule to support QC, network and production requirements.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Applies a systematic approach and uses analytical and critical thinking skills for problem solving.
• Identifies process gaps, introduces innovative solutions, and leads operational excellence projects to improve efficiency and productivity, while decreasing expense/operating costs.
• Leads root cause analysis discussions for more complex problems to develop and efficiently implement effective permanent solutions.
• Seeks out opportunities to permanently improve processes and shares best practices with others.

Win

What we expect of you

Basic 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 leadership experience leading teams, projects, programs or directing the allocation of resources
• Working knowledge of cGMP regulations, practices, and trends pertaining to Quality Control.
• Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources.
• 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 as a member of high performing team.
• Experience in leading and owning complex investigations.
• Experience in auditing and defending processes, procedures and decisions during regulatory inspections.
• Experience with various laboratory computer systems and applications.
• Strong leadership and negotiation skills with a demonstrated ability to influence different styles.
• Demonstrated innovative thinking and ability to transform work organizations.
• Strong technical writing skills within a highly regulated environment.
• Exposure to Operational Excellence initiatives.
• Demonstrated ability to navigate through ambiguity and provide structured problem solving.
• Demonstrated ability to coordinate multi-functional project teams and deliver on schedule.
• Demonstrated skills in staff motivation, coaching/mentoring and professional development.
• Great teammate who is able to collaborate and provide leadership through influence to achieve the required results.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.

• 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 so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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