Job Description

Working in the Finished Goods Platform TPQM (Third Party Quality Management) department within our Research & Development Division. You will be responsible for serving as the quality representative for and providing quality oversight of contractors performing various GMP activities supporting the production of clinical supplies, on behalf of our Company

Key responsibilities include:

• Act as a Lead Quality Liaison for the Quality Oversight of External Entities/CMOs.

• Manage the quality oversight of nominated Third-Party Vendors in the Clinical Finished Goods (FG) Platform.

• Lead internal contractor related issue investigation and resolution teams, review and approval of contractor-initiated investigations associated with deviations, negotiation of site and global Technical and Quality Agreements, participating in contractor GMP audits as a Subject Matter Expert, development and creation of contractor related metrics, conduct of contractor 7deep dive8 quality assessments such in data integrity and leading cross-functional contractor performance reviews as the quality lead for the oversight platform.0

The position will be heavily involved in close collaboration with external contractor quality and technical personnel. Internally interacting closely with Quality Disposition, Pharmaceutical Research/Development and Procurement on strategic objectives-utilizing external contractors including GMP qualification as well as site/project selection.

Additionally, you would lead on projects related to quality oversight of vendors such as helping to develop key quality performance metrics. Serving as the bridge between R&D and Commercialization activities developing strong working relationships with commercial external quality management personnel. In the position you would be the key quality representatives attending and contributing at oversight and business review meetings with members from our company and contractor personnel to discuss projects and quality compliance together with overall performance topics.0

In addition to the job specific responsibilities discussed above, you would be expected to independently execute the following:

• Serve as a Subject Matter Expert managing and investigating significant and complex quality events for external contractors. Leading cross-functional teams related to these events.

• Responsible for approval and assessment of; CMO Quality Events, Audit CAPs, Change Controls.

• Support of the Clinical Supply Chain for our Company's portfolio, specifically in terms of assuring the reliable availability, quality, and regulatory compliance of clinical supplies produced.

• Lead0projects in a matrix management environment.

• Engage in strategic planning across the Quality Unit.

• Make independent decisions and act with authority to carry out required actions.

• Identify and lead implementation of Contractor and Supplier System improvements. Including trends and/or potential compliance gaps and proactively leads the resolution of adverse trends or significant issues in External Entities.0

• Lead others in a matrix/management environment coaches, mentors and develops colleagues in areas of expertise including being an effective team player.

• Lead communication, and serve as the quality spokesperson, on a variety of quality or compliance-related issues with both internal stakeholders and external External Entities.

• Interpret complex regulatory requirements for various audiences, including source area management, and facilitates communication of these requirements across stakeholders.0Reviews draft policy and standards.

• Communicate with senior management within our company and the contractor organization.0 Facilitates and/or prepares cross-functional management presentations.

• Demonstrated time management skills, effectively prioritize and manage conflicting priorities.

Education Minimum Requirement:

• Bachelors Degree in: Pharmacy, Biology, Engineering, Chemistry or related field

Required Experience and Skills:

• At a minimum this position requires a bachelors degree with a minimum of ten (10) + years of relevant experience within the pharmaceutical industry or Advanced Degree with a minimum of eight (8) + years relevant experience.

• Strong scientific/ technical knowledge and experience in R&D activities, coupled with the ability to interact with scientific subject matter experts on various initiatives and resolution of issues in the following areas:

  • Clinical Packaging and Labelling,

  • Distribution of clinical supplies and

  • Dispositioning experience.

Preferred Skills and Experience:

• Leadership and good communication skills (oral and written) effectively with different colleagues/ groups

• Experience in quality disposition and or final batch release.

• Strong compliance knowledge of regulations coupled with proficiency in interpreting and applying GMPs to a R&D environment, especially related to Investigational Medical Products, Finished Goods and Packaging.

• Demonstrated Strategic Project Development and time management skills, ability to conduct well defined projects within discipline or area of expertise.

• Strong scientific/ technical expertise, perspective and judgment in the selected subject matter area coupled with the ability to interact with scientific subject matter experts on various product initiatives.

• Ability to independently interact with regulatory officials and external auditing parties.

• Possess deep drug development knowledge; demonstrated ability to facilitate training and learning in colleagues and apply knowledge to enhance the drug development process.

• Demonstrated knowledge of continuous improvement methodologies; ability to lead matrix teams, recognize improvement opportunities, develop appropriate solutions and follow through on implementation

• Strongly developed cross-functional teamwork, collaboration and negotiation skills

Required Skills:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.0 Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:0We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:0We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeless Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully0
0

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE0the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.