AVP, Quality Systems & Compliance

Job Description

Although one or more potential candidates for this position have been identified via internal succession planning, we will consider applications from any interested applicants. No relocation is provided for this role.

The Position

The Quality Compliance Lead reports directly to the Head of Quality.  The role is responsible for the establishment, maintenance and continuous improvement of the global QMS (Quaity Management System) inclusive of OMS & R&D functions and Global GxP Compliance (cGMP, cGDP, cGVP, cGCP and cGLP). 

The Quality Compliance Lead is responsible for oversight of GxP Audit & Compliance, Operational Quality Oversight of R&D functions, Quality oversight and maintenance of design for medical devices & combination products, the end to end (E2E) complaints management process for pharmaceutical and device products, microbiology, analytical standards management and QMS Operations.

Responsibilities

Primary Responsibilities include, but are not limited to:

• Lead Development and Implementation of Quality Strategy and Planning on behalf of both OMS & R&D
• Report on significant quality issues to senior management
• Develop an annual risk-based audit plan for cGMP audits at all manufacturing sites and external partners, such as external manufacturers, business partners, intermediate & bulk suppliers, excipient and critical / primary component suppliers and other suppliers and service providers
• Develop an annual risk-based audit plan for cGVP audits of PV vendors, affiliates and internal functions to ensure compliance w/ cGVP regulations and expectations
• As operations dictate, execute cGCP / cGLP audits of vendors, study sites and internal functions in support of clinical activities
• Ensure implementation of the audit plan and timely completion of appropriate follow-up activities based on the outcome of the audit
• Direct the Quality Management System (QMS) program to assure ongoing compliance of site and functional QMS
• Maintain and/or change the QMS and any supportive documents / tools
• Ensure each chapter in the QMS has an assigned owner for each subordinate topic
• Ensure Topic Owners have sufficient resources to perform their responsibilities
• Assign a designee to approve global Quality related documents, including quality standards and global procedures
• Provide Quality Oversight for validation and qualification, IT & Quality risk management activities
• Champion Global Quality initiatives and other applicable operational unit or corporate strategic initiatives
• Provide global support for all manufacturing sites regarding product quality complaint processes, case management, trending and metrics
• GxP Quality Lead for R&D and member of the extended R&D Leadership Team

Main activities:

• Final approval of annual schedule of internal/external GxP quality audits
• Final approval of toxicology and medical assessment requests
• Aggregation of GxP risk management inputs & aligning action w/ Global Quality Strategy and Quality Planning
• Defining and monitoring key process and health indicators for action during quality governance
• Develop global quality strategy and quality plan
• Product Quality & R&D Quality inputs for Enterprise Risk Management
• Oversight of the Global Quality Compliance organization of ca. 80 staff

The Quality Compliance Lead is accountable for the following processes for which their direct reports are responsible:

• Updating global quality manual and ensuring the QMS meets the requirements to be compliant, effective and efficient and is appropriately BT enabled
• Writing global quality standards and procedures
• Conducting internal and external Site Quality Audits, including, but not limited to, the external API sites
• Approval of global quality standards
• Approval of global quality procedures
• Approval of quality directives as required

The Quality Compliance Lead chairs the following governance bodies and forums:

• QMS Council
• R&D Quality & Compliance Council
• R&D Quality & Compliance Executive Committee
• Emerging Regulatory Trends Forum

The Quality Compliance Lead owns the following policies through oversight of functions within Global Quality Compliance:

• Organon Corporate Policy 2 – Product Quality
• Quality agreement templates
• Annual Product Reviews
• Auditing (including definition of critical observations, annual schedule of internal/ external divisional quality audits, criteria for approval of site and CMO divisional audit CAPAs)
• Quality council (including metrics and escalations to site, ExM and Platform Quality Councils)
• Criteria for quality directives
• Deviation management (including significant event definitions, incident investigations/definitions, criteria for fact findings)
• Batch disposition
• Regulatory communication
• Change Control

Required Education, Experience, and Skills  

B.Sc (advanced degree preferred) in a relevant field of science and a minimum of 15 years in the biopharmaceutical industry.  Must have a strong background in international GxP policy and regulations.  Must have demonstrated ability and strong experience in using good judgement as a decision-maker in very complex and critical situations where product quality and/or GxP compliance is at issue. 

Must be deeply knowledgeable with the interface between quality assurance and GMP compliance in manufacturing and laboratory operations in order to identify areas for strengthening linkages to achieve overall systemic compliance performance improvement and organizational effectiveness. Ideally has experience in working in operations as well as quality areas. 

Must have a proven track record of directing complex investigations, managing risk, be results driven and capable of rapid decision making.  Must have strong, demonstrated interpersonal, communication, negotiation and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations.  Should have a high degree of emotional intelligence and be a strong collaborator and relationship builder.  A continuous improvement mindset and bias to action is important for this role.  A high focus on delivering efficient solutions is essential.

Key Competencies include:

• GxP Policy & Regulation Implementation
• Quality Strategy Planning & Implementation
• GxP Risk Management
• GxP Audit & Inspection Management
• Quality Operations Expertise
• Organizational Management & Development
• Financial Forecasting & Pharmaceutical Business Acumen
• GxP Product Development & Lifecycle Management Expertise

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. 

Search Firm Representatives Please Read Carefully 
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1