Effectively manages the daily work of direct reports responsible for various QC functions.
- Champions process improvements that have major implications to Laboratory operations as it relates to site production and the Amgen network.
- Mentors employees by sharing technical expertise and providing feedback and guidance. Understands business environment and relates extensive knowledge of industry 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.
- Establishes priorities for teams in line with goals and objectives.
- Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical, compliance and business alternatives.
- Can clearly articulate and educate others sampling, testing and release, sample management, business processes, regulatory and compendia requirements. Translates complex data into actionable information and applies strong technical knowledge to meet business objectives
- Consistently applies a systematic approach and uses exemplary 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.
- Generates enthusiasm, energy, and commitment by expressing a compelling idea or goal
- Seeks out opportunities to permanently improve processes and shares best practices with others.
Basic Qualifications & Experience
- Bachelor's degree or equivalent in science.
- Typically, 8+ years of related professional experience.
- Strong GMP and other applicable GxP knowledge
- Demonstrated experience interacting with regulatory authorities
- Demonstrated experience in evaluating and applying compliance requirements/ guidelines to new and real-life situations
- Fluency in English
Preferred Qualifications & Experience
- Master's degree and 6 years of related experience or Bachelor's degree and 8 years of related experience.
- Working knowledge of cGMP regulations, practices, and trends pertaining to Quality Control.
- Experience in leading and owning complex investigations.
- Proven leadership and management skills, and the ability to handle multiple projects simultaneously.
- Excellent written and verbal communication skills, including facilitation and presentation skills.
- Understanding of biopharmaceutical drug product manufacturing. Demonstrated experience and results in identifying areas of process design and improvement
- This position requires demonstration of strong leadership, negotiation and influencing skills along with advanced communication and analytical skills.
- Amgen is an equal opportunities employer
- Demonstrated ability to find opportunities and implement new technologies and services to transform the business into a more agile, efficient and effective organization
- Ability to deal with complexity and ambiguity, see the big picture, and drive enable relevant business analyses and facilitate decision-making
- 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
- Excellent verbal, written, and communication skills, including the ability to set the context and present on complex subjects to senior management in clear and concise manner
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.