Director Or Sr Director Qa Gcp Jobs

•Management of GCP QA audit initiatives, quality systems, and provision of internal/clinical study team support

•Requires at least 8 years of prior managerial experience

•Bachelor's degree in a scientific field or equivalent qualification

Key areas of responsibility encompass:

•This position holds a direct reporting line to the Vice President of Quality

•Ensures proper and timely escalation of quality matters, including potential misconduct or significant deviations in projects/products

Develop people in the organization through performance management, development plans, coaching, mentoring and challenging assignments.

Manages resourcing, audit plans for internal and external sites, and ensure sites remain qualified to execute their operations under cGMP.

At least 10 years of experience in the Pharmaceutical Industry in areas including Analytical, Quality Assurance/ Quality Control

Previous experience in leadership roles

Experience interacting with Regulatory agencies such as the FDA, EMA, ICH, OSHA and EPA.

Previous experience in Regulatory or MS&T

Manage third party vendor partner performance and workload to support regulatory operations and regulatory publishing.

Manage regulatory budgets, resources, and timelines to optimize operational efficiency and meet business objectives.

Experience in managing regulatory inspections, audits, and interactions with regulatory agencies including direct contact with regulatory agencies.

Final accountability for regulatory documentation, ensuring adherence to FDA and other health authority specifications and timelines

Preference for East Coast-based candidates.

Expert knowledge of ICH, GLP, GCP, and GMP FDA regulatory requirements, with previous experience in the US and Europe

Previous experience as Head of QA preferred

Outstanding interpersonal and communication skills, including scientific writing/editing, presentation, and verbal communication

Provide Quality Assurance oversight and support of ongoing GxP activities for clinical-stage development.

Develop and maintain GxP Standard Operating Procedures (SOPs) policies and controlled documents in partnership with the teams.

Ensure compliance with established company quality policies, practices, standard operating procedures (SOPs) and regulations

Perform all job duties consistent with the 4-I values (Integrity, Intensity, Innovation, and Involvement).

Ability to influence and create an environment to encourage and promote adherence to Quality Assurance policies and requirements.

Minimum 8-10 years of industry experience in Quality Assurance and/or Quality Control with similar leadership experience.

The Sr. Manager, Quality Assurance position is the lead Quality

Serve as Quality member of Product Approval Committees for new product development projects to ensure high-quality product performance in the market.

Serve on PCA Operations Leadership team as Quality Representative and ensuring Quality is included in the Operations strategy.

~8+ years of experience in Quality Assurance, working within clinical research (pharma, biotech or CRO backgrounds are acceptable)

Strong GCP or GXP experience (as an individual, not just working for a company who uses them)

Experience of implementing new electronic systems (both in-house and with vendors) and takes responsible for maintaining the quality of those systems.

You will meet the following requirements:

We are open to all levels from Associate Director to Sr Director.

If you meet the above criteria, please apply immediately with your latest resume for instant consideration.

Develop audit management plans and audit strategy with clients for ongoing clinical trials.

5+ years of experience in a QA department in a related industry;

Experience conducting audits of vendors and investigative sites;

Experience hosting regulatory authorities and interacting with sponsor/client representatives;

Knowledge and application of Good Clinical Practice (GCP) is required;

Medical Device and or Phase 1 experience is a plus;

Medical, dental and vision coverage

401(k) Retirement Savings Plan (with matching)

Short-term and long-term disability, basic life, and accidental death and dismemberment insurance

**Veterans and Military families preferred**

**Prefer Veteran and Military Families**

Taking Care of Our Nation’s Veterans.

Should possess strong interpersonal skills, solid communication skills; both written and oral.

Computer skills: - MS Word, MS Excel

Solid working experience with oscilloscopes, meters, and other instruments to capture data.

Medical, Dental, & Vision benefits - Effective Day 1

Understand and apply formal problem-solving tools.

This individual should be very comfortable engaging at all levels of the organization and shall be independent and a self initiator.

Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered.

Requires solid experience with pharmacovigilance in Phases I-IV (particularly Phase III) and post-marketing.

Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required.

Strong knowledge and understanding of drug and device FDA, EU and ICH regulations, pharmacovigilance regulations/processes and HA inspection procedures is required.

Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices and ICH E-6 for Good Clinical Practice.

Unique offerings of pet, legal, and supplemental life insurance

Ph.D. and 15+ years of relevant experience

Experience contributing to IND & NDA Regulatory Filings

Experience managing tech transfers to internal & external stakeholders

Serve as technical lead for in-house early development and late-stage tech transfer of immediate and controlled release dosage forms.

Lead late-stage NCE Development activities

Work with Regulatory Affairs to develop filing strategies for US and EU

Reports findings to management with recommendations for resolution and verifies appropriate corrective actions have been implemented and documented.

Drafts and issues periodic reports to site management as requested

You have excellent interpersonal skills and ability to work with people in all levels of the organization and externally.

We seek candidates with proven skills in taking initiative and working independently

Good problem solving, written and verbal communication skills

Ability to effectively manage multiple priorities with a sense of urgency

Evaluate audit findings and prepare and distribute responses to operations staff and management.

Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.

Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle.

Good interpersonal communication and organizational skills to establish and maintain effective working relationships with co-workers, managers and sponsors.

Good technology word processing, spreadsheets and database applications skills and knowledge of MS Office applications

Manage Quality Issues and serious breach investigations.

Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed

Communicate escalation issues to management in a timely manner implementing appropriate functional and business solutions and providing regular update

Postgraduate degree (MSC or equivalent) in science or management related discipline preferred

Experience may be substituted for education

A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)

16 years in regulatory environment (experience in GCP roles)

Partner with cross-functional teams, such as development, product, customer support and release management to integrate quality processes throughout the SDLC

Work from home with a remote-first community

In-depth knowledge of QA methodologies, tools, and best practices, including both manual and automated testing

Strong understanding of software development processes, such as Agile or Scrum, and experience working in a continuous integration/continuous deployment (CI/CD) environment

Strong problem-solving skills and the ability to analyze complex issues and identify appropriate solutions

Excellent communication, interpersonal, and leadership skills, with the ability to effectively collaborate with diverse teams and stakeholders

10-12+ years of experience including management of GCP Quality in a pharmaceutical or biotech environment in progressively responsible Quality roles required

Develop metrics to support GCP activities and quality management review

Lead, manage, develop, and mentor direct report(s)

Experience with transition from Phase 1-3 to commercial quality systems is a plus.

Previous experience working with FDA and participating in regulatory agency inspections of clinical research activities

Excellent interpersonal and influencing skills