Assoc. Dir, External Quality

Job Description

Position Overview - Basic Functions & Responsibility

Essential function(s) includes, but is not limited to:

The incumbent is accountable for all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.

The incumbent also ensures that effective and robust Quality systems are followed to comply with required regulations, policies and guidelines governing the External manufacture of materials for the Company (e.g. small molecules, therapeutic proteins, biologics, vaccines, devices, combination products, sterile product, excipients, active pharmaceutical ingredients, intermediates, seeds and cell banks) through direct oversight, support and technical advice, counseling to site leadership, and on-site supervision. The AD may serve as a subject matter expert for EQA and Division in specific Quality systems, technology platforms, regulatory expectations and/or EE management, and can represent the Company in forums on their area of expertise (both internal & external).

Primary Activities

Primary activities include, but are not limited to:

• May manage a team of Quality Assurance professions as direct reports. Holds regular 1-on-1 meetings and Employee Development Plan discussions.

• Accountable for executing the performance management process including objectives setting, objectives approval, objectives revision, year-end accomplishment evaluation, and performance discussions with direct reports, when applicable.

• Contributes to development of the EQA budget and tracks and controls expenses as needed to meet EQA budget.

• Exhibits our company Leadership Behaviors and provides a leadership example for the team.

• Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc) both domestic and foreign.

• Maintains and provides expertise on EQA systems, tools, data, and processes on an ongoing basis.

• Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.

• Accountable for oversight of an EE involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.

• Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied External Entity Oversight Level (EEOL).   These components may include review of batch documentation and deviation investigations.

• Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of Product Quality Review / Annual Product Reviews / Annual Management Review. This also includes building effective quality systems at the EE and continuous improvement activities.

• Manages workload within team scope.

• Operates in a safe and efficient manner and in compliance with the Safety and Health Policy.

• Interacts with local Health Authority (HA) which governs China local CMO site for products local packaging process/operations related topics or requirements to ensure compliance with China local HA regulation/GMP requirements from MAH perspective

Amount of Travel Required: Ability to travel up to 25%, occasionally on short notice and occasional international travel.

Skills

 

REQUIRED: Education and Experience:

• Education: Minimum degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred).

• Minimum of 5 years’ relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements. 

• Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.

• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.

• Communicates fluently in both Mandarin and English, both verbally and in writing. 

 

Preferred Experience and Skills:

• Prior multinational corporation quality assurance/quality control experience

• Prior management experience preferred.

• Moderate level of contractual and financial awareness.

• Experienced at leading Significant Investigations and Fact-Finding Meetings impacting marketed product.

• Previous experience participating in regulatory inspections.

• Be conversant with all domestic and foreign regulations and compendia governing plant operations.

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:

No relocation

VISA Sponsorship:

No

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

25%

Flexible Work Arrangements:

Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1