Job details

Sr. Director, Head of Quality Assurance (GXP)

Oyster Point Pharma, Inc. is now a part of Viatris. Viatris Inc. (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical, and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories.

SUMMARY:

The Viatris Eye Care Division Head of Quality Assurance will assist in leading the Division's Quality program by providing support in assuring adherence to current GXP (Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) compliance) with all regulatory statutes including state, federal, and international regulations, and company policies that govern the development of the Eye Care small molecule pipeline and gene therapies development and all eye care commercial products. In addition, the Head of Quality Assurance will be responsible for integrating the Oyster Point quality system into Viatris and the in the development and maintenance of the company's Quality Systems, specifically around manufacturing; preparation and maintenance of Standard Operating Procedures (SOPs); oversight and participation in auditing program; review and approval of batch-related documentation, including Quality Event review, quality control analyses and product release

Primary Responsibilities

Assure that activities conducted both internally and externally are following applicable laws, regulations and company policies
Verify that drug substance and drug product are manufactured according to cGMPs
Ensure that analytical methods are of the quality required for their intended use and stage of development, incorporating internal quality standards, as well as aligning with cGMP and other drug regulatory requirements.
Manage the writing/reviewing process of Governance Documents (SOP, WI, Forms, Templates, etc.) and GMP operational documentation (MFG and QC)
Recommend, create, implement, and update SOPs, as necessary, to improve processes, and support compliance
Implement, track, and manage quality standards, systems, and metrics for maintaining regulatory compliance for on-site GMP operations
Support improvements and maintenance of the Quality Management System (QMS), including ensuring the system is fully functional in GMP department areas while maintaining compliance with regulatory agencies
Coordinate and conduct audits and report findings & lead potential FDA audits
Act as a compliance resource to provide guidance and assistance towards resolution of moderate to complex deviations, quality investigations, lab investigations, CAPAs and change control
Use of Risk Assessment in quality systems processes
Provide oversight/monitoring of GMP activities which includes internal and external (CMO, CDMO, and CTL), as appropriate

Required Skills:

Bachelor's degree in life sciences or related field required; Master's degree in life sciences or related field preferred.
Minimum of ten years progressive experience in the regulatory compliance environment.
Minimum of seven years Quality auditing experience in the Biotechnology or Pharmaceutical industries required.
Prior supervisory experience preferred.
Strong knowledge of GXPs, FDA regulations and ICH guidelines required. Knowledge of EMA and other Health Authority requirements desired.
Must be able to interpret and apply GXP regulations and guidance, including 21CFR part 11 requirements.
Maintains professional expertise and knowledge of local and international regulations related to Quality.
Must be proficient in MS Office Suite.
Strong knowledge of and ability to navigate Health Authority Websites (e.g. FDA, EMA, ICH).
Prior hands-on experience with electronic data capture systems preferred.
Excellent written and oral communication and presentation skills.
Ability to prioritize and multi-task successfully in a fast paced environment.
Excellent organizational skills and attention to detail are essential.
Ability to: manage both day-to-day operations as well as project work, work both independently and in a collaborative team setting, multi-task and adjust priorities, as necessary, effectively present information to management, participate on interdepartmental teams and interact effectively with all levels of associates both internally and externally, including investigators and health authorities

Other Requirements:

This position requires travel; average travel for this position is 35% with some variation based upon the demands of the business imperatives. Travel is both domestic and international for the purpose of auditing GXP related activities.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $189,520 to $284,280.

We offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others

Oyster Point Pharma Glassdoor Company Review

2.9