Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America
Job Description:
The Senior Manager, Product Quality Integrator, Launch and Grow Biotherapeutics has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization in Launch and Grow for an assigned group of large molecules (biological) products.
Main responsibilities include but are not limited to:
- Represents Global Quality on the Chemistry, Manufacturing, and Controls (CMC) and Value Chain (VCT) Teams. Serves as liaison between VCT and Analytical group. Serves as the single point of Global Quality contact.
- Ensures Quality stage gate deliverables are achieved.
- Quality reviewer/approver of health authority submissions (i.e., IND, IMPD, BLA, NDA, MAA) and associated HA questions on the filings. Approves filings and questions for secondary filings. Support PAI and agency audits for the product(s) assigned.
- Defines and oversees the necessary QA resource for global and local QA of his or her assigned products.
- Leads a comprehensive Quality new product integration team that assures Quality throughout clinical, DS, DP, FF & device: development through launch.
- Leads a comprehensive Quality Sub team that assures Quality throughout clinical, DS, DP, FF & device:
- Ensures product quality development through Launch and Grow stage.
- Supports the sites, represents the sites on CMC and VC teams.
- Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
- Ensures patients get the right quality products
- Ensures standard Global Quality processes (new product introduction processes and norms) are used across sites and facilitates communication throughout Global Quality.
- Manages preparation of the PPQS in advance of Review Board and Executive Management Review.
- Supports preparation of the criticality analysis per schedule.
- Ensures complaints are well managed, issues are understood, and addressed as necessary. Participate in product safety management teams to present Product Quality Complaints trends and topics. Coordinates and/or owner of complaints trend signal investigations.
- Partners with Product Quality Owner (PQO) Value Optimize & Late Stage to complete Transfer of Ownership activities.
- Represents Global Quality on the Value Chain Teams (VCT).
- Maintains the flow of communications between Global Quality and VCT teams.
- Brings Quality issues to the VCT and assists with prioritization of projects and with key product decisions.
- Supports the business continuity process including VCT strategy and BCP projects.
- Reviews Proactive Product Quality Scans with the VCT and assures appropriate mitigating actions are defined there.
- Prepare quality sections of Product Strategy and End-to-end Value Chain Mapping.
- Participate in the F2F VCT meetings on PSR and VCM finalization and project prioritization.
- Align and interface the JSC Product Strategy with other existing strategies: J&J corporate strategies, commercial strategies, R&D strategies, regulatory strategies, etc.
- Presents project updates to QM for Global Quality alignment.
- Escalate issues when appropriate. Works with the cross functional/site teams to coordinate and hold Escalation meetings, minutes archival, follow up on actions.
- Participates and actively engages on IMTs. Supports field/recalls as needed.
- Drives Decision making and Problem Solving:
- Drives/coordinates decisions and makes decisions on behalf of Global Quality including sites.
- Gives input to the development of new strategies and implements and deploys strategies. Aids in the creation of product portfolio guidelines on the control strategy for new products which will influence the development strategy and the total quality cost during commercial production. These include decisions for Design for manufacturability, quality by design versus the cost of development, time to market.
- Aware that quality decisions made at any time during the development of new products can be revisited years later during regulatory inspections and reviews.
- Provides Quality structure, direction and decision making to the teams (Quality, CMC and VC Team) in situations of medium risk, uncertainty and ambiguity.
- Expected to bring creative solutions to define a compliant quality strategy with flexibility for business needs and more complex L&A deals, thus providing the best total value to the company.
Qualifications Required
- A minimum of a bachelor’s degree (or University equivalent) with a major or concentration in one of the following: Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or a similar technical/scientific degree concentration
- A minimum of 8 years’ experience in the pharmaceutical, or biotechnology industry
- Knowledge in cGMP standards, policies and procedures
- Demonstrated ability to work across organizational boundaries through presenting, influencing, negotiation and partnering
- Ability to quickly assimilate new technologies, perform risk assessment and develop action plans
Required Skills:
Preferred Skills:
Business Alignment, Collaboration, Compliance Management, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Mentorship, Organizing, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility
The anticipated base pay range for this position is :
$122,000.00 - $212,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
