Associate Director, Bioanalysis

Associate Director, Bioanalysis – 2406211500W

Description

Johnson and Johnson is currently seeking an Associate Director, Compliance, located in Springhouse, PA.

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the worlds most pressing healthcare challenges.

We know that the success of our business and our ability to deliver meaningful solutions depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

As an Associate Director of Compliance in Bioanalytical Discovery and Development Sciences (BDDS), you will work with internal bioanalytical groups and external partners to enable high quality and compliant data with standard operation procedures and other regulatory guidelines. This is opportunity to support all therapeutic areas within Johnson & Johnson, spanning nonclinical studies to post-market clinical development.

Key Responsibilities:

The Associate Director for Compliance in the Bioanalytical Discovery and Development Sciences (BDDS) group will have responsibility for:

Inspection readiness and participation in Core Inspection Team in support of regulatory inspections

Facilitate conversations for internal study and process audits which includes supporting logistics, scheduling, responses, tracking of entry of CAPAs and resolutions.

Working with external sourcing group to ensure compliance in work being done externally.

Ensures compliance with company standard operation procedures and other regulatory guidelines.

Close collaboration with partnering groups such as Quality Assurance, as needed.

Conducting effective performance management and meaningful career development conversations for employees on their team.

May serve as delegate to the Director of Compliance for most activities, including health authority inspections.

Qualifications

Qualifications

Education:

Ph.D. degree in related fields and 5-8 years of relevant experience, or MS degree or equivalent experience with 10-15 years of relevant experience.

Experience and Skills:

Required:

People leadership experience leading a group of 3 people in a pharmaceutical or CRO bioanalytical group

Excellent communication, interpersonal skills, networking skills, a high level of organizational ability, and attention to detail is required

Expertise in regulatory expectations for the conduct of GLP and clinical bioanalytical support.

Experience with regulatory audits and inspections, inspection readiness activities.

Experience with quality systems and CAPA processes.

Preferred:

Knowledge across a broad array of regulated bioanalytical assays (LBA, LC-MS/MS).

Knowledge of overall drug discovery and development

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.

Primary Location NA-US-Pennsylvania-Spring House

Organization Janssen Research & Development, LLC (6084)

Job Function Pharmacokinetics & Pharmacometrics

Req ID: 2406211500W