17 Senior Director, Quality Assurance Jobs in Cambridge, MA
SORT BY
I
R
S
O
Q
Q
T
B
A
B
I
K
A
P
A
C
B
Senior Director, Quality Assurance
$204k-248k (estimate)
Full Time | Pharmaceutical
5 Days Ago
Olema Oncology is Hiring a Senior Director, Quality Assurance Near Cambridge, MA
Who We Are >>> Why You Should Work With UsOlema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers. Olema’s lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). It is currently being evaluated both as a single agent in an ongoing Phase 3 clinical trial, and in combination with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib), in patients with recurrent, locally advanced or metastatic ER-positive (ER ), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Palazestrant has been granted FDA Fast Track designation for the treatment of ER /HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com, or follow us on Twitter and LinkedIn .
Onto something big, together. Olema is made up of people who are passionate beyond measure. Each and every day, we come together to do amazing things – for each other, for science, and for women with cancer.
Our modern hybrid workplace model encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses.
While at the lab/office, our teams build their camaraderie, opening the door for more authentic mentorship and career development opportunities. While at home, employees can make the most of their time – whether that’s picking up the kids from school, going on a mid-day run, or catching up on chores. Through this model, we strive to offer our employees the best of both work models .
About the Role >>> Senior Director, Quality Assurance As the Senior Director of Quality Assurance, reporting to the Vice President of Regulatory Affairs and Quality Assurance, you will lead all quality activities supporting Olema's pipeline. You will oversee the development, implementation and maintenance of quality assurance systems and activities, and you will lead and build the quality team and function. You will be responsible for managing business relationships with defined stakeholder groups and leaders in the organization for the strategic development and delivery of risk-based quality management and vendor quality oversight.
This role is based out of our Cambridge or San Francisco office and will require 15% travel.
Your work will primarily encompass:
Knowledge:
Important Information >>>We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Additional Note/Fraud Alert: Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema .
Onto something big, together. Olema is made up of people who are passionate beyond measure. Each and every day, we come together to do amazing things – for each other, for science, and for women with cancer.
Our modern hybrid workplace model encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses.
While at the lab/office, our teams build their camaraderie, opening the door for more authentic mentorship and career development opportunities. While at home, employees can make the most of their time – whether that’s picking up the kids from school, going on a mid-day run, or catching up on chores. Through this model, we strive to offer our employees the best of both work models .
About the Role >>> Senior Director, Quality Assurance As the Senior Director of Quality Assurance, reporting to the Vice President of Regulatory Affairs and Quality Assurance, you will lead all quality activities supporting Olema's pipeline. You will oversee the development, implementation and maintenance of quality assurance systems and activities, and you will lead and build the quality team and function. You will be responsible for managing business relationships with defined stakeholder groups and leaders in the organization for the strategic development and delivery of risk-based quality management and vendor quality oversight.
This role is based out of our Cambridge or San Francisco office and will require 15% travel.
Your work will primarily encompass:
- Contribution to the development of the GxP (GLP, GCP/GMP/GPV) Quality Management Systems, conduct risk assessments, develop and implement risk-mitigations and potential process improvements
- Creation and implementation of a GxP inspection readiness strategy and plan in collaboration with leaders in the R&D organization
- Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate
- Oversee all audits and proactively prepare the organization for inspection readiness
- Lead and manage all regulatory inspections in collaboration with internal and external partners
- Ensure the company is compliant and in a constant state of inspection readiness across all GxP functions through continuous education, training, and internal audits
- Implement and maintain quality metrics, systems and documentation associated with developmental activities of Olema's pipeline
- Prepare the QA function to support registrational trials and ultimately commercial activities
- Collaborate with R&D, product, manufacturing, clinical and regulatory teams, as well as external stakeholders to ensure quality standards are integrated throughout the product life cycle
- Provide strategic and managerial leadership in all Quality related matters ensuring regulatory compliance of operational business matters
- Successful quality oversight of Olema’s Quality Management Systems, including Learning Management System and Regulatory Information Management System
- Oversee the development of personnel within the quality department, building a strong team and clear vision to drive best in class performance
- Maintain a pulse on the ever-changing quality assurance landscape and their implementation within Olema, monitor changes in regulations and keep project teams and management informed of such changes
Knowledge:
- Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus
- High level of familiarity with a broad range of compliance areas and ability to assess risk and develop solutions
- Advanced knowledge of Quality Assurance principles, concepts, industry practices and standards
- Strong knowledge of US, EU and other regulatory compliance/GxP requirements
- Deep understanding of small molecule and oncology drug product development
- 15 years of drug development, including 10 years of quality assurance experience in the Biotech/Pharmaceutical industry
- Strong proven hands-on experiences with GLP, GCP, GPV and GMP compliance matters, and contractor management in the bio/pharma industry
- Extensive experience handling regulatory inspections required
- Previous experience with building and implementing QA systems (QMS, RIM, LMS, etc.)
- Experience supporting products from early-stage development to post-approval
- Experience leading BIMO and PAI inspections
- Experience leading and developing team of individual contributors
- Strong business acumen and ability to successfully work with international and cross functional partners
- Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
- Excellent verbal, written and communication skills
- Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders
- Fosters open communication. Listens and facilitates discussion
- Flexible, able to be successful in a past paced, lightly structured environment
Important Information >>>We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Additional Note/Fraud Alert: Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema .
Job Summary
JOB TYPE
Full Time
INDUSTRY
Pharmaceutical
SALARY
$204k-248k (estimate)
POST DATE
06/23/2024
EXPIRATION DATE
07/21/2024
WEBSITE
olemapharma.com
HEADQUARTERS
SAN FRANCISCO, CA
SIZE
25 - 50
FOUNDED
2007
TYPE
Public
CEO
SEAN BOHEN
REVENUE
$5M - $10M
INDUSTRY
Pharmaceutical
Related Companies
About Olema Oncology
Olema is a biopharmaceutical company that develops and commercializes novel therapeutics for the treatment of breast cancer.
Show more
The job skills required for Senior Director, Quality Assurance include Leadership, Quality Assurance, Collaboration, Communication Skills, Process Improvement, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Director, Quality Assurance. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Director, Quality Assurance. Select any job title you are interested in and start to search job requirements.
For the skill of Leadership
Mystic Valley Regional Charter School
Full Time
$54k-80k (estimate)
1 Day Ago
Show more
The following is the career advancement route for Senior Director, Quality Assurance positions, which can be used as a reference in future career path planning. As a Senior Director, Quality Assurance, it can be promoted into senior positions as a Top Quality Assurance Executive that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Senior Director, Quality Assurance. You can explore the career advancement for a Senior Director, Quality Assurance below and select your interested title to get hiring information.
Similar Jobs
Popular Articles
Top 10 Things to Avoid Putting on a Job Application
Read Article
How to Describe Your Education in a Resume
Read Article
How to Write a Memorable Cover Letter in 5 Ways
Read Article
4 Personal Finance Tips to Make During Job Transition
Read Article
4 Best Camera Setups for Interview
Read Article
Keeping a Job Search Journal: 9 Types of Journaling You Can Do
Read Article
