Senior Manager Quality Control

**Senior Manager Quality Control**

**Amgen Singapore Manufacturing, Singapore**

**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** **Amgen Singapore Manufacturing**.

**Senior Manager Quality Control**

**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
- ARA 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**:
**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 establish relationships with partners.
- Track record of building or participating as a member of impactful team.
- Experience in leading and owning complex investigations.
- Experience in auditing and defending processes, procedures and decisions during regulatory inspections.
- 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 professi