AdresSr Mgr, PQM Biologics L&G - 2406169564W
Description
Janssen Supply Group is recruiting for a Sr. Manager PQM Biologics L&G, located in Horsham, PA, Schaffhausen, Switzerland, Wallingstown, Ireland, or Einsteinweg, Netherlands!
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
The Senior Manager, Product Quality, Launch and Grow Biotherapeutics has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization for an assigned group of large molecules (biological) products.
Key Responsibilities:
Represents Global Quality Chemistry, Manufacturing, and Controls (CMC) and Value Chain Team (VCT). Serves as liaison between CMC team, Analytical Development and Product Quality Management. Serves as the single point of Global Quality contact. Drives communication with all Q&C stakeholders.
Assures Quality milestones and Quality stage gate deliverables are achieved.
Quality reviewer of health authority (HA) submissions (i.e., IND, 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 assigned.
Leads a comprehensive Quality Sub team that assures Quality throughout clinical development:
Assures product quality development through Launch and Grow stage.
Supports the sites, represents the sites on CMC and Value Chain Teams (VCT).
Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
Ensures standard Global Quality processes (new product introduction processes, risk assessments, technology transfers) are used across sites and facilitates communication throughout Global Quality.
Leads 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 run, 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 PQ VO&LS to complete Transfer of Ownership activities.
API, RM, FP specifications approvals.
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.
Presents project updates to quality management for Global Quality alignment.
Escalate issues when appropriate. Works with the cross functional/site teams to coordinate and hold Critical issue meetings, minutes archival, follow up on actions.
Participates and actively engages on Issue Management Teams (IMTs). Supports field actions/recalls as needed.
Drives Decision making and Problem Solving:
Drives/coordinates decisions on behalf of Global Quality.
Gives input to the development and deployment of new 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 and time to market.
Provides Quality structure, direction and decision making to the teams (Quality, CMC and VCT) 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 sophisticated L&A deals.
Qualifications
Education:
A minimum of a Bachelor’s degree (or University equivalent) is required with a major or concentration in one of the following: Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific degree concentration.
A Master’s degree or advanced (pharmaceutical, chemical background, biological necessary or a similar degree concentration) is preferred
Experience and Skills:
Required:
A minimum of 8 years of experience in the pharmaceutical, or biotechnology industry is required
In-depth knowledge in cGMP standards, policies and procedures is required
Knowledge of Biotech and/or Sterile Pharmaceutical Manufacturing is required
Experience in technology transfer, process development and/or process validation is required
In-depth understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management and manufacturing control strategies is required
Experience with developing and responding to quality content of regulatory filings, inspections and preparedness activities is required
Demonstrated ability to work across organizational boundaries and within a matrixed organization through presenting, influencing, negotiation and partnering is required
Ability to quickly assimilate new technologies, perform risk assessment and develop action plans is required.
Demonstrated ability to be a strong change facilitator to drive a team towards decisions in an environment with medium levels of ambiguity, complexity and risk is required.
Flexible hours to accommodate US, EMEA and ASPAC work schedules when necessary, balancing work and personal time is required
Preferred:
Consistent track record in leading multifunctional ‘virtual’ teams to success is a plus
Experience with regulatory inspections and preparedness is preferred
Experience in API and Drug Product stability is a plus
Other:
[INSERT Language requirements – relevant language proficiency requirements, if applicable]
[INSERT Travel percentage – specify national or international. Remember, restrictive travel requirements may limit your candidate pool, thus impacting diversity and inclusion.]
The salary for this role, if based within the US, is anticipated to be between $115,000 and $185,000
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be 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.
Employees are eligible for the following time off benefits:
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Primary Location NA-US-Pennsylvania-Horsham
Other Locations Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Switzerland-Schaffhausen, Europe/Middle East/Africa-Ireland-Cork-Cork
Organization JANSSEN SUPPLY GROUP, LLC (6046)
Travel Yes, 10 % of the Time
Job Function Quality Assurance
Req ID: 2406169564W
