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Johnson & Johnson Innovative Medicine · 1 day ago

Director of Sterility Assurance

Raritan, NJ

Full-time

Onsite

Director/Executive

$150K/yr - $259K/yr

10+ years exp

Johnson & Johnson is a leader in healthcare innovation, and they are seeking a Director of Sterility Assurance to oversee microbiological and virological control in product manufacturing. This leadership role involves ensuring compliance with quality standards and providing technical expertise in sterility assurance across the organization.

Pharmaceuticals

Responsibilities

Develop, and maintain oversight of comprehensive microbiology and virology programs, including environmental monitoring, incoming material testing, in-process testing, lot release testing, and stability testing

Serves as primary point of contact and decision maker for internal policies, procedures, and strategy documents governing Sterility Assurance and Contamination Control related topics

Support in knowledge advancement beyond the Quality organization to build, maintain, and develop capabilities across the JNJ network for the Sterility Assurance space. Development of knowledge-based programs to advance company education and training programs

Provide mentoring leadership to stakeholder SMEs to build capability for new and existing sites or where gaps in technical expertise have been identified. Sponsor and oversee activities focused on driving process improvements and harmonization projects across the JNJ network for Sterility Assurance and Contamination Control

Serve as the SME leadership role for topics associated with Sterility Assurance and Contamination Control across the network, representing on network teams and other appropriate governance forums

Provide technical support to during new process design and facility change activities to ensure Sterility Assurance programs and product requirements are supported at the sites. Engage in providing support during regulatory submissions and on-site inspections. Define and execute the process for managing observations and commitments related to Sterility Assurance for the Raritan

Accountable for transformation of sterility assurance global standards across Engineering, MSAT and Quality and ensuring that they are in use across all sites

Set vision for the future to proactively meet regulatory expectations

Accountable for program management for execution / implementation to global standards Deliver Annex 1 compliance through standardized global policies

Implement KPI dashboards for contamination control

Define clear project and governance frameworks to clarify roles and responsibilities between global and local teams

Drive continuous improvement and proactive inspection readiness with storyboard creation and coaching/mentoring

Lead the uplift in capability building and leadership development across functions

Sets and manages targets and objectives for the Raritan site ensuring alignment with overall company strategy

Drives the achievement of annual goals, guided by Our Credo and leadership principles

Builds and sustains strong relationships with internal and external stakeholders, including Global Quality teams, Manufacturing, Quality Control, Facilities and Engineering, and partners

Coordinates quality-related activities across departments, sites, and organizations to proactively support and optimize business processes

Ensure the Sterility Assurance department has a clear organizational structure, with robust formation and succession plans to support long-term stability

Provides leadership to build a high-performing, collaborative team through hiring, mentoring, and talent development

Champions a culture of quality compliance, diversity, inclusion, and continuous improvement

Manages professionals within the Quality team, fostering ongoing talent development and succession planning

Collaborates with the VP, IMSC Quality, and other site Quality Heads as part of the Advanced Therapies Quality Leadership Team (ATQLT) to ensure harmonization and standardization across sites

Partners with cross-functional leaders to support continuous improvement and lifecycle management of GMP policies and the QMS

Represents Raritan in the planning, development, and execution of corporate Quality initiatives

Establishes effective partnerships across business units, sites, and functions to ensure integrated and efficient business processes

Qualification

Quality AssuranceMicrobiologyVirologyCGMP KnowledgeRegulatory ComplianceAseptic ProcessingContamination ControlRisk AssessmentsPeople ManagementBusiness AcumenStrategic ThinkingNegotiation SkillsEffective Communication

Required

A minimum of a Bachelors or equivalent University degree is required with a focus in pharmacy, engineering, chemistry, microbiology or related scientific / engineering discipline preferred

Minimum of 10 years of Quality Assurance / Quality Systems experience related to manufacturing

Comprehensive knowledge of vaccines, biological manufacturing and related Quality management processes and systems

Proven people management and Quality leadership experience

Strong people leadership skills and a proven track record in attracting, developing and retaining talent in the organization

Comprehensive regulatory cGMP and technical knowledge to develop sterility assurance strategies necessary to maintain the desired level of inspection readiness

Experience hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory reviewers

Experience with implementing and overseeing cGMP operations in a commercial manufacturing facility

Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams

Extensive knowledge of chemical, biochemical and microbiological concepts

Knowledge of cGMP regulations and FDA/EU guidance

Fluent in English (written and spoken)

Preferred

Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is highly preferred

Strategic thinking with the ability to manage/master complexity and to act as a sponsor for change

Ability to prioritize and guide the organization in coping with the demands of a rapidly changing environment

Ability to apply appropriate risk assessment strategies to manage business & compliance priorities

Effective negotiation and influencing skills and lead with a mindset of continuous improvement

Balanced decision-making skills and ability to effectively resolve conflict, when needed

Business acumen; develop and control budgets

Ability to communicate effectively with different levels in the organization and with health authorities

Benefits

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.

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