Quality Compliance Associate Director Aseptic Processing

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity and obesity-related conditions. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Quality Compliance Associate Director Aseptic Processing
What you will do

Lets do this. Lets change the this vital role you will serve as a Quality Compliance microbiology subject matter expert supporting contamination control QC microbiology manufacturing microbiology inspection readiness and technical consistency across Amgen Operations. This role partners with Quality Manufacturing Process Development Regulatory Affairs-CMC Cellular Sciences site laboratories and global technical networks to ensure science-based compliant and practical decisions.

This is a full-time remote position

Specific responsibilities include but are not limited to:

• Serve as a aseptic processing and contamination control subject matter expert for Quality Compliance Manufacturing and site teams.

• Support the contamination control program including site engagement network participation metrics review risk identification and escalation of significant concerns.

• Contribute to the development revision and implementation of global aseptic processing and contamination control standards procedures technical guidance and quality intelligence documents.

• Support periodic contamination control reviews trend evaluations and state-of-control assessments for in-scope sites processes and products.

• Provide technical input for environmental monitoring bioburden control endotoxin microbial identification disinfectant efficacy cleaning and disinfection gowning aseptic practices utilities facilities and laboratory controls.

• Partner with site Quality Manufacturing Engineering and QC laboratories to promote consistent application of contamination control expectations.

• Provide technical review and recommendations for microbiology investigations deviations CAPAs risk assessments change controls audit observations and inspection commitments.

• Support evaluation and implementation of new or improved technologies practices and contamination control tools.

• Contribute to Global Aseptic Council activities technical forums communities of practice and network alignment discussions.

• Support regulatory inspections internal audits health authority commitments and inspection-readiness activities related to microbiology contamination control QC laboratories and manufacturing controls.

• Provide technical input to audit responses regulatory inspection responses CAPA plans and effectiveness checks.

• Review regulatory filings responses or technical documents for aseptic processing -related content as assigned.

• Monitor relevant regulatory compendial and industry developments and help translate them into practical expectations for sites and functions.

• Lead or support cross-functional projects related to aseptic processes contamination control laboratory practices inspection readiness or quality improvement.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The Quality Compliance Associate Director Aseptic processing we seek is an experienced collaborative subject matter expert with these qualifications.

Basic Qualifications:

• Doctorate degree and 3 years of Quality Microbiology Manufacturing or relevant regulated industry experience OR

• Masters degree and 7 years of Quality Microbiology Manufacturing or relevant regulated industry experience OR

• Bachelors degree and 9 years of Quality Microbiology Manufacturing or relevant regulated industry experience

• Associates degree and 12 years of Quality Microbiology Manufacturing or relevant regulated industry experience OR

• High school diploma / GED and 14 years of Quality Microbiology Manufacturing or relevant regulated industry experience

In addition to meeting at least one of the above requirements you must have a minimum of 3 years experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• Life Science Microbiology Biology Biological Sciences Pharmaceutical Sciences Biotechnology Engineering or related scientific academic background.

• 8 years of experience in Quality QC microbiology Manufacturing contamination control sterility assurance or a related GMP function within the biotechnology or pharmaceutical industry.

• 3 years of experience in aseptic processing leading environmental monitoring programs or contamination control technical workstreams.

• Strong technical knowledge of aseptic processing microbiology and contamination control practices including environmental monitoring bioburden endotoxin microbial identification disinfectant efficacy cleaning and disinfection gowning aseptic practices utilities facilities and laboratory controls.

• Experience supporting GMP investigations deviations CAPAs change controls risk assessments audits inspection readiness or regulatory inspection activities.

• Experience in biologics sterile manufacturing aseptic processing drug substance manufacturing drug product manufacturing or QC microbiology laboratory operations.

• Experience contributing to global or multi-site standards procedures technical guidance training materials quality intelligence or quality system improvements.

• Ability to interpret and apply GMP GxP regulatory compendial and industry expectations to microbiology manufacturing Quality Control and contamination control processes.

• Experience supporting or participating in technical networks communities of practice Centers of Excellence or cross-site microbiology forums.

• Experience evaluating or implementing new manufacturing technologies rapid microbiological methods automation data trending tools or contamination control improvements.

• Demonstrated ability to lead cross-functional teams influence without direct authority communicate complex technical information clearly and manage multiple priorities.

• Ability to work effectively with global and virtual teams across time zones while adapting approaches based on technical complexity regulatory considerations and stakeholder needs.

• Effective English written and verbal communication skills; additional language capability is a plus.

• Ability to travel domestically and internationally up to 20% of the time.

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts

• A discretionary annual bonus program or for field sales representatives a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.

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