The Validation Senior Manager is accountable for supporting day-to-day business with process engineering and scientific knowledge and resources; focused on site and/or project execution and support. S/He works closely with the local value stream leads and validation engineers.
Responsibilities:
- Develops and implements validation procedures for manufacturing facilities to ensure compliance with company standards and regulatory guidelines.
- Develops and maintains statistical, risk-based standards for validation activities and regulatory submission strategies.
- Develops and maintains documentation for new and current validation procedures and technical reports related to systems, products and/or processes.
- Develops and maintains programs and standard operating procedures (SOPs) and provides technical support/training on validation and regulatory requirements.
- Lead cross-functional teams for complex projects at the site or global level to support process changes, process improvements, and/or large capital projects (Tier 1 and Tier 2).
- Collaborate with site and global validation team members, as well as cross-functionally with individuals in multi-department teams to develop and implement validation approaches to execute capital projects. Work independently with other groups and communicates decisions to manager.
- Serve as Subject Matter Expert for validation. Represent and speak for the department in cross-functional meetings at the site level or globally; key contributor for project support and/or process support.
- Ensure that customer expectations are met for business KPIs and work priorities. Provides support for issues that impact product quality, validation, and GMP compliance.
- Support on-time closure of deviations, CAPAs, change controls and regulatory commitments. Supports large complex projects locally and/or globally.
Qualifications:
- Undergraduate degree in Engineering/Science
- 7+ years’ related experience required, in pharmaceutical/biotech operations, 3+ years validation experience
- Leadership/management experience
- Direct experience with regulated environments (i.e. cGMP, FDA, EMA) required, with direct experience supporting biannual or pre-approval inspections preferred.
- Strong communication and conflict management skills to influence project professionals and stakeholders, including non‐specialists, at all levels in the organization.
- Demonstrated experience in managing, organizing, developing and deploying best practice frameworks, processes, tools and templates in an Operations context, in alignment with Enterprise standards
- Involvement in cross-functional, multicultural and international teams
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
The expected base salary range for this position at hiring is $126,900 - $136,900. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
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