Quality Compliance Manager
Remote, MA 02110
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: Quality Compliance Manager
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: Perm
- Pay rate: $130k
- Job Location: Remote
- Job#: bh 14134
Quality Compliance Manager
The Manager/Senior Manager, Quality Compliance position is responsible for leading and performing independent GMP audits, assessments of contract manufacturers, suppliers and GMP service providers. This position leads GMP audits, resolution of audit findings, and liaises with appropriate site quality through all stages of the audit lifecycle. The Manager/Senior Manager, Quality Compliance may lead or participate in other quality compliance related activities.
- Manage and lead or participate in GMP audits and assessments of contract manufacturers, suppliers and GMP service providers involved in the manufacture, packaging, testing and distribution of APIs, clinical trial materials and commercial pharmaceutical products worldwide.
- Assess if the auditee is executing operations in compliance with cGMP requirements and guidelines, Quality Standards and Quality Agreement requirements and SOPs.
- Communicate relevant quality information to the contract manufacturer, supplier or GMP service provider audited, in an effort to maintain and enhance the relationship between the auditee and company.
- Interpret regulatory and business challenges and best practices, report risks or weaknesses that could lead to cGMP compliance issues and recommend required improvements or solutions.
- Lead or participate in GMP audits at contract manufacturers, suppliers and GMP service providers. Responsibilities for these activities include but are not limited to:
- Lead negotiations with auditees to schedule audits
- Lead audit preparation activities including gathering of and review of auditee’ relevant quality and performance metrics to determine risk-based audit scope
- Lead the audit execution, or actively participate in the audit execution as directed by the lead auditor
- Lead the preparation of audit reports
- Lead the review and evaluate the adequacy of the auditee response to audit findings
- Perform audit follow-up activities as required or as directed by leadership
- In appropriate situations, initiate reviews through consultation and agreement with others, including subject matter experts
- Maintain the appropriate audit database with relevant records and information pertaining to the lifecycle of assigned audits
- Maintain and expand current knowledge of applicable laws, regulations, guidelines, internationally recognized standards and other pertinent policies, procedures, and standards that could impact the auditee’s operations
- Lead or participate in due diligence assessments as required to assess auditee’s Quality compliance
- Able to collaborate proactively with leadership, site personnel and subject matter experts, to enable a culture of excellence in independent objective audits and effective CAPAs
- Develop cross functional collaborative relationships to facilitate engagement, team building, best practice sharing, risk-based analysis, critical thinking and innovative problem solving
- Lead or participate in department initiatives to advance the business strategy of the GMP audit function
- As assigned, aid the auditee in preparing for upcoming regulatory inspections.
- Support or participate in negotiation of Quality Agreement with CMOs or CTLs.
- Support or participate in other quality activities as assigned, e.g. Management Review, product complaints, Annual Product Review, etc.
- Bachelor’s Degree in pharmaceutical sciences or equivalent required
- Minimum 8 years of progressive experience in the pharmaceutical industry required, inclusive of quality control, quality assurance, manufacturing and GMP auditing.
- Proven knowledge and experience in GMP auditing of at least 3 technology platforms and areas of specialization such as small molecules, drug products, active pharmaceutical ingredients, laboratory operations (chemistry, microbiology, specialized), computerized systems, good distribution practices.
- Must understand the elements and requirements of the Quality Management System at different types of GMP vendors.
- Has a strong understanding of relevant regulatory and audit frameworks that apply to pharmaceutical operations, has in-depth knowledge of cGMP requirements and expectations, is familiar with global regulations and internationally recognized standards (e.g., FDA, EU, PIC/S, ISO), and is capable of understanding and reacting to emerging regulations and business / regulatory trends.
- Critically evaluates information from the auditee and is able to identify risk areas in the field. Has the ability to recognize symptoms of problems or situations that require further evaluation, and analyze symptoms to determine potential causes and identify possible solutions
- Ability to make clear recommendations and communicate effectively. Can independently determine when input from subject matter experts is necessary. Anticipates potential objections and influences others to ensure appropriate outcomes
- Ability to lead diverse audits and effectively interact with personnel of multicultural backgrounds. Has the ability to communicate and interact with colleagues and business partners at all levels of the organization
- Ability to work independently and work well as a lead auditor or participant, and is an effective communicator to peers, managers and leadership inside and outside the company
- Good organization skills for audit preparation, execution and report issuance in adherence to procedural requirements. Actively works to achieve a balanced audit plan, supportive of urgent audit requests and flexible to changes
- Write audit reports to reflect the required style and content, with meaningful findings levelled appropriately
- Ability to conduct ad hoc GMP assessments (e.g., data integrity, quality culture, due diligence, mock inspection) as required to support business needs.
- Demonstrated ability to apply the following competencies and soft skills: business skills (negotiation, logical reasoning, critical thinking, decision making, presentation skills); leadership skills (persuasive communication, active listening, active learner); relationship skills (stakeholder management, social perceptiveness, relationship building); and supporting technical skills (technical writing, digital acumen, data analytics)
- Recognized audit certification (e.g., ASQ) is desirable
- Experience in shop floor quality assurance is desirable
- Ability to travel up to 30-40%, including domestic and international
The successful candidate will also embody our values:
Our purpose is to create value for those we have the privilege to serve:
- We take pride in our work
- We keep our promises and deliver
- We are driven to meaningfully innovate
- We succeed through inclusion and teamwork
Committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
We requires all employees be fully vaccinated by an approved vaccine against COVID-19, including a booster dose if it has been more than eight months since the employee’s original vaccination, unless you need an exemption due to disability, pregnancy or conditions related to pregnancy or religion or unless otherwise provided by law; in the case of exemption, weekly testing will be required.
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