Manager/Sr. Manager, Validation
Manager/Sr. Manager, Validation
This role is responsible for providing support and proactive strategic planning for QA oversight of validation activities. The Manager/Sr. Manager, Validation is responsible for managing validation activities and works with internal and external stakeholders, participates cross functionally, providing their own expertise and experience to ensure that validations are in compliance with regulatory requirement. The Validation Manager is the subject matter expert (SME) in support of regulatory authority inspections to address audit findings, CAPAs and deviations. The Validation Manager also develops and/or reviews SOPs, validation protocols/reports, and associated documents.
Good things are happening at Omeros!
Come join our Omeros Regulatory Affairs & Quality Systems Team!
Who is Omeros?
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros’ proprietary G proteincoupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.
What are your job responsibilities?
- Manages the validation system from a Quality Assurance perspective to ensure that Quality and Compliance requirements are met in an efficient and effective manner, and in support of corporate objectives
- Provides Quality oversight and support for process, cleaning, shipping, computer system, equipment and instrument qualification and validation activities
- Provides Quality oversight and support for method qualification, method transfer and method validation activities
- Acts as the Quality / Validation SME for Change Controls supporting GXP systems
- Provides leadership and guidance to staff on qualification/validation issues.
- Reviews and updates SOPs to support internal and external validation programs, identifying the need for new SOPs, and developing new SOPs, as needed
- Assists with the preparation, coordination, and management regulatory inspections
Education, Experience, Skills, and Knowledge Required:
- Bachelor’s degree in a life science or Engineering with a minimum 5 + years’ direct experience in validation working in the pharmaceutical and/or biotech industry for a Manager level and 7+ years for a Sr. Manager level
- E xperience in the areas of software applications development/ support in the pharmaceutical or related industries is desired
- Areas of expertise must include process, cleaning, shipping, computer system, equipment, and instrument qualification, method qualification/validation, and ICH/GXP knowledge
- In-depth knowledge and clear understanding of GXP regulations and industry standards
- Excellent organizational, planning and prioritizing skills
- Exceptional communication skills, both written and verbal
- Effective cross-functional and intra-functional collaboration skills
- Demonstrated success in building and maintaining relationships as well as influencing internal and external colleagues and collaborators
- The ability to present in a professional manner and write routine reports and correspondence
- Strong computer skills in applications used in general office settings such as word processing, spreadsheet, presentation, data base management, and internet search engine applications
- Strong decision-making, situation analysis, and creative problem-solving skills
Behavioral Competencies Required:
- Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates
- Integrity and flexibility
- A proven attention to detail and an orientation for meticulous, high-quality work
- This role requires 20% to 30% travel, both domestic and international
Physical Demands Required:
- Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 20 lbs.
- May encounter prolonged periods of sitting or standing
Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.
It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to firstname.lastname@example.org or contact Omeros, asking for Human Resources, at (206) 676-5000