Senior Manager, Quality Assurance & Regulatory Strategic Initiatives
Serves as the Quality lead for all strategic expansion projects. Responsible for assuring project activities are in agreement with Kankakee site, CSL Behring and industry standards regarding Quality Assurance, Validation, Change Management and Compliance requirements. Assures appropriate documentation is provided to support project activities including product license requirements. Required to review and approve Validation and Technical Transfer protocols and reports, Project Plans, User Requirements and other project related documentation to assure proper quality attributes are included.
While tasks are performed in support of project activities, responsible for ensuring quality oversight for manufacturing areas, timely batch record review, deviation investigations including root cause, corrective action/preventative action and continuous improvement.
Requirements:
Main Responsibilities and Accountabilities
1. Serves as primary Quality contact and provides Quality leadership for all expansion projects.
2. Responsible for management of Quality resources necessary to perform and implement multiple expansion projects in parallel, including capital budgets, project cost estimates, timelines, and personnel resources.
3. Responsible for assuring that project activities are in agreement with Kankakee site, CSL Behring and industry standards regarding Quality Assurance, Validation, Change Management and Compliance requirements.
4. Quality representative for development of strategy, schedule and metrics to transition new facilities into commercial operations and responsible for achieving project objectives/schedule.
5. Provides support to design teams to assure that facilities and systems being developed are in alignment with current regulatory agency expectations.
6. Provides Quality input to project related Design Phase documentation review and approval (ie. automation, sampling, cross contamination, etc.). Directly supports issue and discrepancy resolution from QA perspective while assuring adherence to facility SOPs.
7. Provides Quality oversight of project changes and directs the project team in all change management activities that impact the Quality System. Directs or participates in risk assessment development, as needed.
8. Provides Quality oversight for qualification documentation in support of Engineering activities, including Commissioning, IQ and OQ execution, as well as HVAC and Utility/Facility qualification documents.
9. Responsible for the Quality oversight of Installation, Operation and Performance Qualification of HVAC, Utilities, Facilities and Equipment, as well as the Cleaning Validation, Process Validation and Computer Validation.
10. Required approver of Validation Master Plans, Project Plans, Protocols and Summary Reports for all Validation activities for expansion projects, and management of scientifically sound validation strategies.
11. Quality interface with CEQ, VCR and User Lead teams, and participates as Quality representative on Operation Readiness and Gate Review Teams, as requested.
12. Oversees the Quality release to Engineering Runs and Conformance batch production, and transition of Quality responsibilities to facility responsible departments.
13. While tasks are performed in support of project activities, overall management responsibility of deviation investigations ensuring they are properly classified by risk and investigated thoroughly, well written and reviewed/approved in a timely manner including root cause analysis to drive robust CAPAs, and managed in order to meet DIFOT schedule for consistent supply of product to patients.
14. Manages all preparation activities and participate in Regulatory authority audits to support project execution and approval.
15. Maintains an intimate knowledge of biological regulations, including draft and final regulations and assist in ensuring that awareness of these regulations exists within project team.
16. Participates, as needed, in the interview and selection process for individual and corporate resources required for project execution.
Qualification Requirements
Education : BS or BA degree in Biology, Chemistry, Biochemistry or related field; MS preferred.
Experience :
Minimum eight years experience working in a pharmaceutical or other FDA regulated industry, applying cGMPs as part of daily activities. Minimum 5 years regulatory affairs experience. Minimum three years experience supervising two or more staff members. Technical transfer and regulatory audit experience a plus.
Competencies
In-depth knowledge of cGMPs. Must demonstrate strong leadership qualities, excellent written and oral communication skills, ability to interpret and apply cGMP and quality principles in daily work, and strong computer/technical skills. Ability to work in a team environment. Expert knowledge of FDA technical requirements and of CSL Behring product license files essential. Working knowledge of US and international drug and biologics guidelines and regulations. Direct experience with FDA, ideally including hands-on experience working with the FDA and International regulatory authorities from pre-approval to post-marketing. Problem solving abilities, creativity, and efficient time management. Analytical and conceptual thinking. Efficient use of networking. Decisiveness. Action oriented, organizational agility, global business knowledge, and motivating others.
Worker Type:
Employee
Worker Sub Type:
Regular
