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Validation Manager
Orca Bio
Administration
Sacramento, CA, USA
Posted on Oct 8, 2024
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
The Validation Manager will oversee validation activities for equipment, systems, and processes in a cGMP-regulated environment, reporting to the Site Quality Head. This role manages a team of three direct reports and ensures compliance with regulatory and operational requirements. The validation of systems plays a crucial role in our Quality Policy, ensuring systems are reliable and meet the data integrity requirements to support rapid processing times. The role requires a hands-on approach, driving efficient project execution and maintaining high standards of validation across the site. This role will oversee the development and management of the Validation Master Plan, ensure compliance with regulatory standards, and coordinate all validation activities including cleaning validation, equipment validation, and validation execution.
Responsibilities
- Manage and lead the validation team, ensuring successful execution of all validation activities, including equipment qualification, computerized system qualification, process validation, and system implementation in compliance with regulatory standards.
- Develop, maintain, and manage the Validation Master Plan to ensure compliance with regulatory requirements and industry best practices.
- Direct and actively participate in equipment qualifications, process validations, and system implementations to ensure timely and compliant completion of projects.
- Collaborate with cross-functional teams to ensure that validation activities align with project timelines and objectives.
- Develop and implement templates and processes to optimize validation efforts, ensuring both compliance and operational efficiency.
- Write, review, and approve validation protocols, reports, risk assessments, trace matrices, and SOPs to meet regulatory and internal requirements.
- Stay current with industry practices and regulatory requirements, applying FDA 21 CFR Part 11, Annex 11, and other relevant guidelines to validation strategies.
- Serve as a key contact during internal and external audits, ensuring validation activities are audit-ready and compliant with regulatory standards.
- Responsible for presenting audit findings and maintaining a strong quality culture throughout the organization.
- Ensure that cleaning validation protocols and reports meet regulatory standards and support product quality and safety.
- Provide hands-on support for validation activities, including troubleshooting and complex investigations, ensuring ongoing compliance with the validation lifecycle.
- Develop and implement risk-based approaches for equipment validation, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
- Lead, mentor, and develop the validation team and stakeholders in validation best practices, promoting a culture of compliance and continuous improvement.
- Foster a collaborative work environment that encourages continuous improvement and innovation in validation practices.
- Stay current with industry regulations, standards, and best practices related to validation and quality assurance.
Qualifications
- Bachelor’s degree in a scientific or engineering discipline preferred.
- 5-10 years of experience in a pharmaceutical or cGMP-regulated environment, with hands-on experience in equipment and system validation.
- Strong knowledge of validation principles, risk assessments, and regulatory standards such as cGMP, 21 CFR Part 11, and Annex 11.
- Demonstrated leadership experience managing a validation team.
- Excellent technical writing skills, with experience in change control, deviation management, and regulatory documentation.
- Ability to manage multiple projects and work independently with a proactive, hands-on approach.
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
To learn more: https://orcabio.com/join-our-team/
**all official communication will be from @orcabio.com; please beware of scams**
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.