Technical Manager - Technical Change Management

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Oceanside, CA
In-Office
78K-144K Annually
Healthtech • Biotech
The Role

 

The Opportunity:

Join our dynamic team as a Technical Manager (TCM), where you'll play a key role in ensuring quality systems and processes run smoothly. We value collaboration, efficiency, and a commitment to maintaining the highest standards in documentation and change control. This is a unique opportunity to apply your technical expertise and skills while making a significant impact across departments, guiding teams through complex challenges and driving continuous improvement.

What you’ll do:  

  • Function as a Change Controller by assessing, reviewing, approving and closing change

  • records.

  • Management of documents and change records on direct impact systems and identify

  • qualification requirements to ensure the validated state is maintained or established. Collaborate with departments to ensure that all review activities are executed efficiently and

  • effectively.

  • Promote and provide guidance in Good Documentation Practices.

  • Apply advanced theory, technical principles, expert judgment, and cross-functional expertise

  • To independently address a broad range of complex problems

  • Establish work priorities to meet targets and timelines

  • Serve as a technical subject matter expert (SME) on Quality systems, process and issues

Who You Are:

  • 5-7 years of experience with a BS/BA in Life Science field or equivalent 
  • 3-5 years of experience with a Masters in Life Science field or equivalent 

  • Must understand Quality standards and policies, GMPs, Health Authority Regulations and Validation practices/principles. 

  • Excellent communication skills, verbal and written. 

  • Demonstrated ability to manage multiple activities while maintaining a high level of organization. 

  • Demonstrates initiative; ability to undertake additional responsibilities and respond to situations as they arise with little or no supervision. 

  • Demonstrated ability to work as part of a team and collaborate effectively with staff at all levels. 

Days worked:  M-F Days

  • Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of California is $77,500 to $143,900.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

 

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

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The Company
HQ: South San Francisco, CA
20,069 Employees
Year Founded: 1976

What We Do

Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years.

Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.

We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal.

Making a difference in the lives of millions starts when you make a change in yours.

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