Technical Compliance Lead (GxP Manufacturing)

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description:

The role is part of the Manufacturing Site Technology Sustainment team, responsible for the end to end Compliance & Validation activities. This role will be responsible to provide oversight and adherence of all periodic & data integrity tasks. This individual will assist with investigations and leverages domain and business process expertise to detail technical findings, along with supporting artifacts. This role involves working closely with business analysts, quality and system owners to ensure that systems are maintained and kept in validated state of operations. You will collaborate with site compliance leads to  maintain an efficient and consistent process, ensuring quality deliverables from the team.

Roles & Responsibilities:

• Accountable for team of Compliance Analyst in support of Compliance activities at the manufacturing sites
• Responsible for the computer validation / compliance (computer validation, validation lifecycle processes, DTI data integrity, inspection readiness)
• Responsible for the schedule adherence of the GxP periodic review & Data Integrity activities
• Collaborate with Site Compliance or Validation Lead to review and mitigate exceptions, ensuring conformance to regulatory requirements
• Collaborate with Global Quality, Compliance Teams and System owners to ensure alignment with Amgen standards and requirements
• Provide support to assist in investigation of deviations, data integrity risks and events
• Provide experienced technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardizing and improving new and existing equipment
• Prepare, execute, document, and report validation protocols in line with GMP’s and other regulatory requirements and standards
• Assure that all validation test procedures are in line with current technology, corporate, and governmental regulations
• Perform IQ, OQ, and PQ validation on processes, equipment, and systems in conjunction with suppliers as appropriate
• Maintain high quality documentation of GxP documents

Basic Qualifications and Experience:

• Any degree with 8 - 13 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience 

Functional Skills:

Must-Have Skills (Not more than 3 to 4):

• In-depth knowledge of Part 11/Annex 11 computer system, data integrity and validation processes, requirements, and policies
• Knowledge and experience in application of risk based approaches to computer validation
• Has strong technical writing skills  

• Excellent problem solving, communication skills and the ability to interface with cross functional leadership with confidence and clarity

Good-to-Have Skills:

• Understanding of scientific software systems strategy, governance, and infrastructure
• Able to communicate technical or complex subject matters in business terms
• Jira Align experience
• Knowledge of network security protocols and tools (e.g., IPSEC, SSL, IDS/IPS, firewalls)

Professional Certifications (please mention if the certification is preferred or mandatory for the role):

• SAFe for Teams certification (preferred)

Soft Skills:

• Able to work under minimal supervision
• Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work
• Excellent analytical and gap/fit assessment skills
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully
• Team-oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills

Shift Information:

This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

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 with 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.